A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures

NCT00522041 | Completed Phase 3 Results

• 1 other identifier: REC-C-01
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fissure in Ano; Pain

Keywords

Pain associated with chronic anal fissure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Intensity at Days 14-18

  Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.

  Baseline to Day 18

Secondary Outcomes (2)

• Time to an Improvement in Pain Intensity

  Baseline to Day 21

• Percentage of Responders

  Baseline to Day 18

Study Arms (2)

Cellegesic (nitroglycerin 0.4%)

EXPERIMENTAL

Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.

Drug: Cellegesic

Placebo 375 mg

PLACEBO COMPARATOR

Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.

Drug: Placebo

Interventions

Cellegesic DRUG

Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.

Also known as: 0.4% nitroglycerin ointment, Rectogesic

Cellegesic (nitroglycerin 0.4%)

Placebo DRUG

Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.

Placebo 375 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Related Publications (1)

• Berry SM, Barish CF, Bhandari R, Clark G, Collins GV, Howell J, Pappas JE, Riff DS, Safdi M, Yellowlees A. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013 Jul 1;13:106. doi: 10.1186/1471-230X-13-106.

  PMID: 23815124 DERIVED

MeSH Terms

Conditions

Fissure in Ano; Pain

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Results Point of Contact

• Title: Susan Fox, PhD
• Organization: Allergan plc

susan.fox@allergan.com

201-427-8225

Study Officials

• Gemma Clark

  Strakan Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 3, 2016
• Results First Posted: November 3, 2016

Record last verified: 2016-09