Clinical trial NCT01054820: Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Official title: Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Back Strain
Keywords: FLECTORÂ® Patch
acute back strain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Participants in the study must:

1. have acute, non-radicular back strain with onset up to 10 days before the first visit
2. have intact, non-damaged skin at the proposed patch application site
3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids
4. 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")
5. have a normal neurologic examination

Exclusion Criteria:

Participants may not be in the study if they:

1. have had surgery or other chronic pain condition within 3 months before first treatment
2. have back pain radiating below the knee at time of enrollment
3. have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy
4. are being treated for or are known to currently have kidney or liver disease
5. have certain other diseases or are using certain types of other drugs.

Primary outcomes:
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)
Secondary outcomes:
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)
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)
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)
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)
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)
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)
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)
measure: Mean Change From Baseline to EOT in Beck Depression Inventory® Il
timeFrame: Baseline, End of Treatment (last visit up to Day 15)
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)
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)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: