Trial · NCT00522041

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

NCT00522041, Phase 3, Completed, Forest Laboratories; results first posted 2016-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures. Trials, record NCT00522041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00522041

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
NCT number: NCT00522041
Status: Completed
Phases: Phase 3
Enrollment: 248 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Fissure in Ano, Pain
Interventions: Cellegesic, Placebo
First posted: 2007-08-29
Last updated: 2016-11-03
Results first posted: 2016-11-03

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Pain Intensity at Days 14-18	Baseline to Day 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.
Secondary	Time to an Improvement in Pain Intensity	Baseline to Day 21	Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. 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. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity.
Secondary	Percentage of Responders	Baseline to Day 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. 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 responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Pain Intensity at Days 14-18	Baseline to Day 18	Intent-to-treat population: All randomized participants who had applied the study medication at least once.	Units on a scale	MEAN
SECONDARY	Time to an Improvement in Pain Intensity	Baseline to Day 21	Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis.	Days	MEAN
SECONDARY	Percentage of Responders	Baseline to Day 18	Intent-to-treat population: All randomized participants who had applied the study medication at least once.	Percentage of responders	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Pain Intensity at Days 14-18	Cellegesic (Nitroglycerin 0.4%)		-40.4	Standard Error 3.12	Units on a scale
Change From Baseline in Pain Intensity at Days 14-18	Placebo		-34.9	Standard Error 3.04	Units on a scale
Time to an Improvement in Pain Intensity	Cellegisic (Nitroglycerin 0.4%)	≥ 50% decrease	10.7	Standard Error 0.6	Days
Time to an Improvement in Pain Intensity	Placebo	≥ 50% decrease	13.2	Standard Error 0.7	Days
Time to an Improvement in Pain Intensity	Cellegisic (Nitroglycerin 0.4%)	≥ 10 mm decrease	6.1	Standard Error 0.5	Days
Time to an Improvement in Pain Intensity	Placebo	≥ 10 mm decrease	7.2	Standard Error 0.6	Days
Percentage of Responders	Cellegisic (Nitroglycerin 0.4%)	≥ 50% decrease	72.4		Percentage of responders
Percentage of Responders	Placebo	≥ 50% decrease	64.5		Percentage of responders
Percentage of Responders	Cellegisic (Nitroglycerin 0.4%)	≥ 10 mm decrease	88.6		Percentage of responders
Percentage of Responders	Placebo	≥ 10 mm decrease	85.5		Percentage of responders

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cellegesic (Nitroglycerin 0.4%)	123
Overall Study	STARTED	Placebo	125
Overall Study	Received Treatment	Cellegesic (Nitroglycerin 0.4%)	123
Overall Study	Received Treatment	Placebo	124
Overall Study	COMPLETED	Cellegesic (Nitroglycerin 0.4%)	106
Overall Study	COMPLETED	Placebo	113
Overall Study	NOT COMPLETED	Cellegesic (Nitroglycerin 0.4%)	17
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Cellegesic (Nitroglycerin 0.4%)	86	123
other	Headache	Nervous system disorders	Placebo	59	124
other	Dizziness	Nervous system disorders	Cellegesic (Nitroglycerin 0.4%)	6	123
other	Dizziness	Nervous system disorders	Placebo	2	124
other	Nausea	Gastrointestinal disorders	Cellegesic (Nitroglycerin 0.4%)	2	123
other	Nausea	Gastrointestinal disorders	Placebo	5	124
other	Diarrhoea	Gastrointestinal disorders	Cellegesic (Nitroglycerin 0.4%)	4	123
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	124
other	Sinusitis	Infections and infestations	Cellegesic (Nitroglycerin 0.4%)	3	123
other	Sinusitis	Infections and infestations	Placebo	1	124

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cellegesic (Nitroglycerin 0.4%)
Total, all-cause mortality	Placebo
Total, other adverse events	Cellegesic (Nitroglycerin 0.4%)	96	123
Total, other adverse events	Placebo	67	124
Total, serious adverse events	Cellegesic (Nitroglycerin 0.4%)	2	123
Total, serious adverse events	Placebo	1	124

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23815124	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cellegesic (Nitroglycerin 0.4%) vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00522041

GET https://conductscience.org/api/trials/v1/NCT00522041/registered

API reference For AI assistants