Phase 3
N=248
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
Fissure in Ano · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00522041 ↗Enrolled (actual)
248
Serious AEs
1.2%
Results posted
Nov 2016
Primary outcome: Primary: Change From Baseline in Pain Intensity at Days 14-18 — -40.4; -34.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cellegesic (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Intensity at Days 14-18 |
-40.4; -34.9 | — |
| SECONDARY Time to an Improvement in Pain Intensity |
10.7; 13.2; 6.1; 7.2 | — |
| SECONDARY Percentage of Responders |
72.4; 64.5; 88.6; 85.5 | — |
Summary
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.
The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.
Eligibility Criteria
Inclusion Criteria
- Consenting patients of either sex.
- Between 18 and 75 years of age.
- With a single, chronic, posterior midline anal fissure.
- Defined as having anal pain for the 6 weeks prior to Screening.
Exclusion Criteria
- More than one anal fissure.
- A fistula-in-ano or anal abscess.
- Inflammatory bowel disease.
- Fibrotic anal stenosis.
- Anal fissure secondary to an underlying condition.
- Any anal surgery.
- Concomitant medication that may interfere with study evaluation.
Data sourced from ClinicalTrials.gov (NCT00522041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.