Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-03 @ 10:17 PM
Study NCT ID:
NCT00346268
Status:
TERMINATED
Last Update Posted:
2011-10-28
First Post:
2006-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'C409945', 'term': 'parecoxib'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, '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': 'This study was terminated prematurely due to slow recruitment.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.', 'otherNumAtRisk': 52, 'otherNumAffected': 35, 'seriousNumAtRisk': 52, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.', 'otherNumAtRisk': 53, 'otherNumAffected': 38, 'seriousNumAtRisk': 53, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infected lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pelvic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.84', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '36.40', 'spread': '19.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least square (LS) mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.58', 'ciLowerLimit': '-14.63', 'ciUpperLimit': '-0.53', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.55', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hours post surgery', 'description': 'Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population (FAS): participants who were randomized to treatment'}, {'type': 'SECONDARY', 'title': 'Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.13', 'spread': '25.02', 'groupId': 'OG000'}, {'value': '57.03', 'spread': '28.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least square (LS) mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.16', 'ciLowerLimit': '-25.47', 'ciUpperLimit': '-4.85', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.20', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 hours post surgery', 'description': 'Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Time to Last Administration of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '123.7'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '90.3'}]}]}], 'analyses': [{'pValue': '0.257', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by center', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline (end of surgery) to 48 hours post surgery', 'description': 'Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Number of participants analyzed (N)=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Amount of Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.34', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.810', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.53', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 hours post surgery', 'description': 'Calculated as: (\\[Hb g/dL\\]pra + RBCUduring48)-\\[Hb g/dL\\]at 48, where \\[Hb g/dL\\]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), \\[Hb g/dL\\]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': '1 RBC transfused unit', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 RBC transfused units', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours post surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': 'At rest, prior to admin, 12 hours post surgery', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'At rest, post admin, 12 hours post surgery', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'At movement, prior to admin, 12 hours post surgery', 'categories': [{'measurements': [{'value': '2.12', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'At movement, post admin, 12 hours post surgery', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'At rest, prior to admin, 24 hours post surgery', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'At rest, post admin, 24 hours post surgery', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'At movement, prior to admin, 24 hours post surgery', 'categories': [{'measurements': [{'value': '2.12', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'At movement, post admin, 24 hours post surgery', 'categories': [{'measurements': [{'value': '1.45', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'At rest, prior to admin, 36 hours post surgery', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'At rest, post admin, 36 hours post surgery', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'At movement, prior to admin, 36 hours post surgery', 'categories': [{'measurements': [{'value': '1.59', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'At movement, post admin, 36 hours post surgery', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'At rest, prior to admin, 48 hours post surgery', 'categories': [{'measurements': [{'value': '0.67', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'At rest, post admin, 48 hours post surgery', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'At movement, prior to admin, 48 hours post surgery', 'categories': [{'measurements': [{'value': '1.47', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'At movement, post admin, 48 hours post surgery', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12, 24, 36, and 48 hours post surgery', 'description': 'Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).\n\nMovement defined as sitting up from a lying into a sitting position in bed.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': '24 hours post surgery (n=49, 50)', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': '48 hours post surgery (n=43, 48)', 'categories': [{'measurements': [{'value': '1.60', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.26', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': '24 hours post surgery', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '-0.23', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': '48 hours post surgery', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 and 48 hours post surgery', 'description': 'mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': '24 hours post surgery (n=49, 50)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': '48 hours post surgery (n=43, 48)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '1.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '-0.56', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': '24 hours post surgery', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference (net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '-0.24', 'pValueComment': 'Adjusted for treatment group and center', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': '48 hours post surgery', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 and 48 hours post surgery', 'description': 'mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.'}, {'type': 'SECONDARY', 'title': 'Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': '24 hours post surgery', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': '48 hours post surgery', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 and 48 hours post surgery', 'description': "Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.", 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Rating of Global Evaluation of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours post surgery', 'description': 'Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N=participants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Health Care Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours post surgery', 'description': 'Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to study termination.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Analgesic Benefit Score (OABS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours post surgery', 'description': "Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.", 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to study termination.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemoglobin Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'paramType': 'NUMBER', 'timeFrame': '24 hours post surgery', 'unitOfMeasure': 'g/dL', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to study termination.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Amount of Postoperative Drainage Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'OG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'paramType': 'NUMBER', 'timeFrame': '24 hours post surgery', 'description': 'After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.', 'unitOfMeasure': 'mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to study termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'FG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant refused', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This study was terminated prematurely due to slow recruitment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Parecoxib and Morphine', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'BG001', 'title': 'Placebo and Morphine', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 45 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 59 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Between 60 and 74 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-21', 'studyFirstSubmitDate': '2006-06-28', 'resultsFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2006-06-28', 'lastUpdatePostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-21', 'studyFirstPostDateStruct': {'date': '2006-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Rating of Global Evaluation of Study Medication', 'timeFrame': '48 hours post surgery', 'description': 'Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.'}, {'measure': 'Number of Participants With Health Care Resource Utilization (HCRU)', 'timeFrame': '24 and 48 hours post surgery', 'description': 'Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".'}, {'measure': 'Overall Analgesic Benefit Score (OABS)', 'timeFrame': '24 and 48 hours post surgery', 'description': "Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24."}, {'measure': 'Hemoglobin Concentration', 'timeFrame': '24 hours post surgery'}, {'measure': 'Total Amount of Postoperative Drainage Fluid', 'timeFrame': '24 hours post surgery', 'description': 'After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.'}], 'primaryOutcomes': [{'measure': 'Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery', 'timeFrame': '24 hours post surgery', 'description': 'Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery', 'timeFrame': '48 hours post surgery', 'description': 'Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.'}, {'measure': 'Time to Last Administration of Morphine', 'timeFrame': 'baseline (end of surgery) to 48 hours post surgery', 'description': 'Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).'}, {'measure': 'Amount of Blood Loss', 'timeFrame': '48 hours post surgery', 'description': 'Calculated as: (\\[Hb g/dL\\]pra + RBCUduring48)-\\[Hb g/dL\\]at 48, where \\[Hb g/dL\\]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), \\[Hb g/dL\\]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.'}, {'measure': 'Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units', 'timeFrame': '48 hours post surgery'}, {'measure': 'Pain Intensity Score', 'timeFrame': '12, 24, 36, and 48 hours post surgery', 'description': 'Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).\n\nMovement defined as sitting up from a lying into a sitting position in bed.'}, {'measure': 'Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score', 'timeFrame': '24 and 48 hours post surgery', 'description': 'mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).'}, {'measure': 'Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score', 'timeFrame': '24 and 48 hours post surgery', 'description': 'mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.'}, {'measure': 'Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score', 'timeFrame': '24 and 48 hours post surgery', 'description': "Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '25767411', 'type': 'DERIVED', 'citation': 'Dirkmann D, Groeben H, Farhan H, Stahl DL, Eikermann M. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial. BMC Anesthesiol. 2015 Mar 9;15:31. doi: 10.1186/s12871-015-0015-y. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3481066&StudyName=Morphine-Sparing%20Efficacy%20Of%20Parecoxib%20In%20Pain%20Treatment%20After%20Radical%20Prostatectomy', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.', 'detailedDescription': 'The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,\\<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.\n* The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.\n\nExclusion Criteria:\n\n* The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results\n* The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease."}, 'identificationModule': {'nctId': 'NCT00346268', 'acronym': 'PROSTATECTOMY', 'briefTitle': 'Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'A3481066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine plus Parecoxib', 'interventionNames': ['Drug: Morphine, Parecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine and Placebo', 'interventionNames': ['Drug: Morphine, Placebo']}], 'interventions': [{'name': 'Morphine, Parecoxib', 'type': 'DRUG', 'description': 'Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.', 'armGroupLabels': ['Morphine plus Parecoxib']}, {'name': 'Morphine, Placebo', 'type': 'DRUG', 'description': 'Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA', 'armGroupLabels': ['Morphine and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '69121', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '72764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}