A Phase 3 interventional study of Diclofenac Sodium and Matching Placebo Patch in Acute Pain and Ankle Sprain, sponsored by Cerimon Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-01-28.
Sponsored by Cerimon Pharmaceuticals · Phase 3, Interventional, and Treatment
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 219 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Cerimon Pharmaceuticals is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Diclofenac Sodium
Drug: Matching Placebo Patch
Topical diclofenac patch applied once daily to area of pain
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Change in average pain during daily activity at Day 3
Time frame: Day 3
Change in average pain during daily activity at Day 7
Time frame: Day 7
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Cerimon Pharmaceuticals