Fissure in AnoPhase 3NCT00522041
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
A Phase 3 study testing Cellegesic in people with Fissure in Ano and Pain, run by Forest Laboratories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fissure in Ano, Pain
- What is being tested?
- Cellegesic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomized. Double-blind, Placebo-controlled, Multi-national Study to Determine the Effect of Cellegesic Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With a Chronic Anal Fissure
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
- Being tested
- Cellegesic, Placebo
- Keywords
- Pain associated with chronic anal fissure
- Medical subject headings
- Fissure in Ano, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellegesicDrug
Also called 0.4% nitroglycerin ointment, Rectogesic
Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.
PlaceboDrug
Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 18
Secondary outcomes (2)
Time to an Improvement in Pain Intensity
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.
Measured: Baseline to Day 21
Percentage of Responders
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.
Measured: Baseline to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fissure in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gemma Clark, Study director, Strakan Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522041
- Sponsor's protocol ID
- REC-C-01
- Status last verified
- Sep 2016
- First submitted
- 28 Aug 2007
- Last updated
- 3 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23815124
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized. Double-blind, Placebo-controlled, Multi-national Study to Determine the Effect of Cellegesic Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With a Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT00522041
- Acronym / sponsor ID
- REC-C-01
- Conditions
- Fissure in Ano, Pain
- Keywords
- Pain associated with chronic anal fissure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Posted 3 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellegesic (nitroglycerin 0.4%) | Experimental | Drug: CellegesicParticipants 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. |
| Placebo 375 mg | Placebo comparator | Drug: PlaceboParticipants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellegesicAlso: 0.4% nitroglycerin ointment, RectogesicCellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin. | Drug | Cellegesic (nitroglycerin 0.4%) |
| PlaceboPlacebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin. | Drug | Placebo 375 mg |
Primary outcome
Change From Baseline in Pain Intensity at Days 14-18
Time frame: 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.
2 secondary outcomes
Time to an Improvement in Pain Intensity
Time frame: Baseline to Day 21
Percentage of Responders
Time frame: Baseline to Day 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23815124Berry 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.
Related trials for Fissure in Ano
RecruitingObservational study
Ultrasound Assessment After Surgery for Chronic Anal Fissure
Anal Fissure Chronic
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
AI-Assisted Written Information in Chronic Anal Fissure
Chronic Anal Fissure
Recruiting
Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
Anal Fissure Chronic
Not yet recruitingObservational study
Female Sexual Function After Surgery for Benign Perianal Diseases
Chronic Anal Fissure, Hemorrhoidal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Clark study director
Strakan Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cellegesic in people with Fissure in Ano and Pain, run by Forest Laboratories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Intensity at Days 14-18 (time frame: Baseline to Day 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.