Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01054820
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2010-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.', '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': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.', 'otherNumAtRisk': 123, 'otherNumAffected': 15, 'seriousNumAtRisk': 123, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.46', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '-3.95', 'spread': '2.51', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'groupDescription': 'Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Change at EOT: Bsl=Yes, EOT=Yes', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Change at EOT: Bsl=Yes, EOT=No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Change at EOT: Bsl=No, EOT=Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at EOT: Bsl=No, EOT=No', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.59', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '-4.50', 'spread': '2.48', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.46', 'spread': '1.84', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '-3.50', 'spread': '2.30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.49', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '-4.28', 'spread': '2.28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.94', 'spread': '11.23', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '67.30', 'spread': '30.58', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': '5=Complete Relief', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': '4=A Lot Of Improvement', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': '3=Moderate Improvement', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '2=Slight Improvement', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '1=No Change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (up to Day 15)', 'description': 'Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': '5=Complete Relief', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': '4=A Lot Of Improvement', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': '3=Moderate Improvement', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '2=Slight Improvement', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '1=No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (up to Day 15)', 'description': "Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to EOT in Beck Depression Inventory® Il', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.44', 'spread': '5.47', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline to EOT', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '3.05', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': "The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and \\>40=extreme depression.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; End-of-Treatment score was the most recent non-missing value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': '5=Very Satisfied', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': '4=Satisfied', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': '3=No Preference', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '2=Dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '1=Very Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (last visit up to Day 15)', 'description': 'Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'classes': [{'title': '5=Very Satisfied', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': '4=Satisfied', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': '3=No Preference', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '2=Dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '1=Very Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (last visit up to Day 15)', 'description': "Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.', 'description': 'One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2010-01-20', 'resultsFirstSubmitDate': '2012-07-10', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-10', 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.'}, {'measure': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).'}, {'measure': 'Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': 'Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).'}, {'measure': 'Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant', 'timeFrame': 'End of Treatment (up to Day 15)', 'description': 'Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.'}, {'measure': 'Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator', 'timeFrame': 'End of Treatment (up to Day 15)', 'description': "Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change."}, {'measure': 'Mean Change From Baseline to EOT in Beck Depression Inventory® Il', 'timeFrame': 'Baseline, End of Treatment (last visit up to Day 15)', 'description': "The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and \\>40=extreme depression."}, {'measure': 'Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant', 'timeFrame': 'End of Treatment (last visit up to Day 15)', 'description': 'Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.'}, {'measure': 'Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator', 'timeFrame': 'End of Treatment (last visit up to Day 15)', 'description': "Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FLECTOR® Patch', 'acute back strain'], 'conditions': ['Acute Back Strain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=K353-09-4001&StudyName=Study%20to%20Assess%20the%20Effectiveness%20and%20Safety%20of%20FLECTOR%20Patch%20for%20Treatment%20of%20Acute%20Back%20Strain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants in the study must:\n\n1. have acute, non-radicular back strain with onset up to 10 days before the first visit\n2. have intact, non-damaged skin at the proposed patch application site\n3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids\n4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating of zero (0) being "no pain" and a rating of ten (10) being "pain as bad as you can imagine")\n5. have a normal neurologic examination\n\nExclusion Criteria:\n\nParticipants may not be in the study if they:\n\n1. have had surgery or other chronic pain condition within 3 months before first treatment\n2. have back pain radiating below the knee at time of enrollment\n3. have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy\n4. are being treated for or are known to currently have kidney or liver disease\n5. have certain other diseases or are using certain types of other drugs.'}, 'identificationModule': {'nctId': 'NCT01054820', 'briefTitle': 'Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain', 'orgStudyIdInfo': {'id': 'K353-09-4001'}, 'secondaryIdInfos': [{'id': 'B4811001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLECTORA Patch (diclofenac epolamine topical patch) 1.3%', 'description': 'One patch applied every 12 hours', 'interventionNames': ['Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%']}], 'interventions': [{'name': 'FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%', 'type': 'DRUG', 'description': "One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.", 'armGroupLabels': ['FLECTORA Patch (diclofenac epolamine topical patch) 1.3%']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}