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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Acute Back Strain

Treatments: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054820

K353-09-4001

B4811001

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

123 participants in 1 patient group

FLECTORA Patch (diclofenac epolamine topical patch) 1.3%

Experimental group

Description:

One patch applied every 12 hours

Treatment:

Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%