Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-02 @ 12:54 AM
Study NCT ID:
NCT00553605
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2007-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007660', 'term': 'Ketoprofen'}, {'id': 'C409945', 'term': 'parecoxib'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'PR at all time points, proportion of participants with \\>= 1 grade improvement in PR 30 min were replaced by PR at 30 and 120 min; number of participants with response in PI included; time to RM reported as number, due to change in planned analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.', 'otherNumAtRisk': 174, 'otherNumAffected': 47, 'seriousNumAtRisk': 174, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.', 'otherNumAtRisk': 164, 'otherNumAffected': 55, 'seriousNumAtRisk': 164, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Urethral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Pain Intensity Difference at 30 Minutes (mPID30min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.147', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '35.266', 'spread': '3.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-6.53', 'ciUpperLimit': '4.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.75', 'groupDescription': 'LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Minute 30', 'description': 'mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.'}, {'type': 'SECONDARY', 'title': 'Mean Pain Intensity Difference at 120 Min (mPID120min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.608', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '51.697', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-5.04', 'ciUpperLimit': '4.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.52', 'groupDescription': 'p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Minute 120', 'description': 'mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.'}, {'type': 'SECONDARY', 'title': 'Time-specific Pain Intensity (PI) VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'title': 'Baseline (n= 173, 164)', 'categories': [{'measurements': [{'value': '77.14', 'spread': '17.92', 'groupId': 'OG000'}, {'value': '76.99', 'spread': '18.26', 'groupId': 'OG001'}]}]}, {'title': 'Minute 15 (n= 173, 164)', 'categories': [{'measurements': [{'value': '50.42', 'spread': '26.92', 'groupId': 'OG000'}, {'value': '50.95', 'spread': '24.65', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30 (n= 172, 162)', 'categories': [{'measurements': [{'value': '34.13', 'spread': '28.57', 'groupId': 'OG000'}, {'value': '33.65', 'spread': '26.64', 'groupId': 'OG001'}]}]}, {'title': 'Minute 45 (n= 163, 156)', 'categories': [{'measurements': [{'value': '21.75', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '23.15', 'spread': '24.93', 'groupId': 'OG001'}]}]}, {'title': 'Minute 60 (n= 156, 152)', 'categories': [{'measurements': [{'value': '14.62', 'spread': '21.25', 'groupId': 'OG000'}, {'value': '17.53', 'spread': '23.17', 'groupId': 'OG001'}]}]}, {'title': 'Minute 90 (n= 151, 144)', 'categories': [{'measurements': [{'value': '9.80', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '12.27', 'spread': '20.22', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120 (n= 147, 139)', 'categories': [{'measurements': [{'value': '7.68', 'spread': '14.29', 'groupId': 'OG000'}, {'value': '8.02', 'spread': '15.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minute 15, 30, 45, 60, 90, 120', 'description': 'PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively."}, {'type': 'SECONDARY', 'title': 'Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'title': 'Minute 15 (n= 173, 164)', 'categories': [{'measurements': [{'value': '26.72', 'spread': '24.59', 'groupId': 'OG000'}, {'value': '26.04', 'spread': '26.13', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30 (n= 172, 162)', 'categories': [{'measurements': [{'value': '42.89', 'spread': '28.70', 'groupId': 'OG000'}, {'value': '43.22', 'spread': '29.39', 'groupId': 'OG001'}]}]}, {'title': 'Minute 45 (n= 163, 156)', 'categories': [{'measurements': [{'value': '54.37', 'spread': '27.82', 'groupId': 'OG000'}, {'value': '53.55', 'spread': '27.98', 'groupId': 'OG001'}]}]}, {'title': 'Minute 60 (n= 156, 152)', 'categories': [{'measurements': [{'value': '61.35', 'spread': '25.44', 'groupId': 'OG000'}, {'value': '59.34', 'spread': '26.28', 'groupId': 'OG001'}]}]}, {'title': 'Minute 90 ( n= 151, 144)', 'categories': [{'measurements': [{'value': '65.99', 'spread': '22.88', 'groupId': 'OG000'}, {'value': '64.33', 'spread': '25.05', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120 (n= 147, 139)', 'categories': [{'measurements': [{'value': '68.07', 'spread': '21.14', 'groupId': 'OG000'}, {'value': '68.51', 'spread': '21.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '-4.28', 'ciUpperLimit': '5.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'groupDescription': 'Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.866', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-6.22', 'ciUpperLimit': '5.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.91', 'groupDescription': 'Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-4.38', 'ciUpperLimit': '6.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.70', 'groupDescription': 'Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.290', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.62', 'ciLowerLimit': '-2.24', 'ciUpperLimit': '7.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.47', 'groupDescription': 'Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.16', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '6.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.14', 'groupDescription': 'Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.926', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '3.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'groupDescription': 'Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Minute 15, 30, 45, 60, 90, 120', 'description': 'PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'n' signifies participants who were evaluable at specific time points for each treatment arm respectively."}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '362.42', 'spread': '10.65', 'groupId': 'OG000'}, {'value': '352.29', 'spread': '10.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.451', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.13', 'ciLowerLimit': '-16.3', 'ciUpperLimit': '36.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.43', 'groupDescription': 'p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Minute 120', 'description': 'TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pain Relief (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'title': 'Minute 30: none (n= 171, 162)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: a little (n= 171, 162)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: some (n= 171, 162)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: a lot (n= 171, 162)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: complete (n= 171, 162)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: none (n= 146, 139)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: a little (n= 146, 139)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: some (n= 146, 139)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: a lot (n= 146, 139)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: complete (n= 146, 139)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3982', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5552', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Minute 30, 120', 'description': 'PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response in Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9785', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.007', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.69', 'groupDescription': 'p-value was based on logistic regression model with terms for treatment group and baseline as covariates.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Minute 30', 'description': 'PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation of Study Medication", 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'title': 'Minute 30: poor', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: fair', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: good', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: excellent', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: poor', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: fair', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: good', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: excellent', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2482', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7659', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Minute 30, 120', 'description': 'Participants\' response to the question "How would you rate the study medication you received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': "Physician's Global Evaluation of Study Medication", 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'title': 'Minute 30: poor', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: fair', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: good', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Minute 30: excellent', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: poor', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: fair', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: good', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Minute 120: excellent', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9783', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6847', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Minute 30, 120', 'description': 'Physicians\' response to the question "How would you rate the study medication the patient received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Use of Rescue Medication (RM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'OG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9645', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Minute 120', 'description': 'Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'FG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Did not receive full dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Parecoxib', 'description': 'Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.'}, {'id': 'BG001', 'title': 'Ketoprofen', 'description': 'Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 18 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Greater than or equal to (>=) 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2007-11-02', 'resultsFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-20', 'studyFirstPostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pain Intensity Difference at 30 Minutes (mPID30min)', 'timeFrame': 'Minute 30', 'description': 'mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.'}], 'secondaryOutcomes': [{'measure': 'Mean Pain Intensity Difference at 120 Min (mPID120min)', 'timeFrame': 'Minute 120', 'description': 'mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.'}, {'measure': 'Time-specific Pain Intensity (PI) VAS Score', 'timeFrame': 'Baseline, Minute 15, 30, 45, 60, 90, 120', 'description': 'PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.'}, {'measure': 'Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120', 'timeFrame': 'Baseline, Minute 15, 30, 45, 60, 90, 120', 'description': 'PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.'}, {'measure': 'Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)', 'timeFrame': 'Baseline through Minute 120', 'description': 'TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.'}, {'measure': 'Number of Participants With Pain Relief (PR)', 'timeFrame': 'Minute 30, 120', 'description': 'PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.'}, {'measure': 'Number of Participants With Response in Pain Intensity', 'timeFrame': 'Minute 30', 'description': 'PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.'}, {'measure': "Patient's Global Evaluation of Study Medication", 'timeFrame': 'Minute 30, 120', 'description': 'Participants\' response to the question "How would you rate the study medication you received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.'}, {'measure': "Physician's Global Evaluation of Study Medication", 'timeFrame': 'Minute 30, 120', 'description': 'Physicians\' response to the question "How would you rate the study medication the patient received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.'}, {'measure': 'Number of Participants With Use of Rescue Medication (RM)', 'timeFrame': 'Up to Minute 120', 'description': 'Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal Colic Pain Urinary Tract Colic'], 'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3481065&StudyName=Efficacy%20And%20Safety%20Of%20Parecoxib%2040mg%20vs.%20Ketoprofen%20100mg%20In%20The%20Management%20Of%20Acute%20Renal%20Colic', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales\n\nExclusion Criteria:\n\n* The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.\n* The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.'}, 'identificationModule': {'nctId': 'NCT00553605', 'acronym': 'NAP', 'briefTitle': 'Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic', 'orgStudyIdInfo': {'id': 'A3481065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Ketoprofen plus placebo parecoxib', 'interventionNames': ['Drug: Ketoprofen 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Parecoxib plus placebo ketoprofen', 'interventionNames': ['Drug: Parecoxib 40mg']}], 'interventions': [{'name': 'Ketoprofen 100mg', 'type': 'DRUG', 'description': "Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection", 'armGroupLabels': ['I']}, {'name': 'Parecoxib 40mg', 'type': 'DRUG', 'description': 'Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CEP 20551-030', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14015-130', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '09715-090', 'city': 'São Bernardo do Campo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.69389, 'lon': -46.565}}, {'zip': '04262-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04321-120', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04122-000', 'city': 'Vila Mariana - São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site'}, {'zip': '7500921', 'city': 'Providencia', 'state': 'Santiago, RM', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'Alajuela', 'state': 'Alajuela Province', 'country': 'Costa Rica', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 10.01723, 'lon': -84.21275}}, {'city': 'Desamparados', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 9.89747, 'lon': -84.06345}}, {'city': 'San José', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Quito', 'state': 'Pichincha', 'country': 'Ecuador', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'San Pedro Sula', 'state': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}, {'zip': 'L 31', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'L27', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}