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Trial record 20 of 346 for:    sprains and strains

Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

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ClinicalTrials.gov Identifier: NCT01054820
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Back Strain
Intervention Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Period Title: Overall Study
Started 123
Completed 121
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants
38.8  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
60
  48.8%
Male
63
  51.2%
1.Primary Outcome
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
Hide 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).
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 6.46  (1.30)
Change from baseline to EOT -3.95  (2.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
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
Hide 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.
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
Change at EOT: Bsl=Yes, EOT=Yes 93
Change at EOT: Bsl=Yes, EOT=No 21
Change at EOT: Bsl=No, EOT=Yes 0
Change at EOT: Bsl=No, EOT=No 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method McNemar
Comments [Not Specified]
3.Secondary Outcome
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
Hide 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).
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 7.59  (1.19)
Change from baseline to EOT -4.50  (2.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
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
Hide 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).
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 5.46  (1.84)
Change from baseline to EOT -3.50  (2.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now
Hide 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).
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 6.49  (1.76)
Change from baseline to EOT -4.28  (2.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline
Hide 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).
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 2.94  (11.23)
Change from baseline to EOT 67.30  (30.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
Hide 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.
Time Frame End of Treatment (up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
5=Complete Relief 53
4=A Lot Of Improvement 42
3=Moderate Improvement 12
2=Slight Improvement 12
1=No Change 4
8.Secondary Outcome
Title Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
Hide 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.
Time Frame End of Treatment (up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
5=Complete Relief 58
4=A Lot Of Improvement 42
3=Moderate Improvement 8
2=Slight Improvement 10
1=No Change 5
9.Secondary Outcome
Title Mean Change From Baseline to EOT in Beck Depression Inventory® Il
Hide 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.
Time Frame Baseline, End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; End-of-Treatment score was the most recent non-missing value.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 3.44  (5.47)
Change from baseline to EOT -1.54  (3.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
Hide 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.
Time Frame End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
5=Very Satisfied 63
4=Satisfied 45
3=No Preference 6
2=Dissatisfied 8
1=Very Dissatisfied 1
11.Secondary Outcome
Title Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
Hide 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.
Time Frame End of Treatment (last visit up to Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
5=Very Satisfied 66
4=Satisfied 39
3=No Preference 9
2=Dissatisfied 8
1=Very Dissatisfied 1
Time Frame 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.
Adverse Event Reporting 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.
 
Arm/Group Title FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Hide Arm/Group 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.
All-Cause Mortality
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Affected / at Risk (%)
Total   1/123 (0.81%) 
General disorders   
Non-cardiac chest pain  1  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Affected / at Risk (%)
Total   15/123 (12.20%) 
Cardiac disorders   
Tachycardia  1  2/123 (1.63%) 
Gastrointestinal disorders   
Diarrhoea  1  1/123 (0.81%) 
Abdominal discomfort  1  1/123 (0.81%) 
Abdominal pain  1  1/123 (0.81%) 
Nausea  1  1/123 (0.81%) 
Infections and infestations   
Folliculitis  1  1/123 (0.81%) 
Gastroenteritis viral  1  1/123 (0.81%) 
Upper respiratory tract infection  1  1/123 (0.81%) 
Injury, poisoning and procedural complications   
Application site rash  1  3/123 (2.44%) 
Application site pruritus  1  1/123 (0.81%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/123 (0.81%) 
Nervous system disorders   
Headache  1  1/123 (0.81%) 
Psychiatric disorders   
Depressed mood  1  1/123 (0.81%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01054820     History of Changes
Other Study ID Numbers: K353-09-4001
B4811001
First Submitted: January 20, 2010
First Posted: January 22, 2010
Results First Submitted: July 10, 2012
Results First Posted: August 16, 2012
Last Update Posted: August 16, 2012