A double-blind, placebo-controlled, randomised, multi-centre, dose-ranging study to determine the safety and efficacy of three concentrations of topical diltiazem cream in the treatment of chronic anal fissure. - Diltiazem cream for chronic anal fissure
- Conditions
- Chronic anal fissureMedDRA version: 8.1Level: LLTClassification code 10002153Term: Anal fissure
- Registration Number
- EUCTR2006-003931-63-GB
- Lead Sponsor
- S.L.A. Pharma (UK) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 352
For inclusion in the study, subjects must satisfy all of the following criteria:
1. Male or female subjects aged = 18 years who have given written, informed consent.
2. Symptomatic, chronic anal fissure (pain on or following defecation) present for =4 weeks and presenting with notable fissure-related pain.
3. Evidence of circumscribed fissure, with induration at the edges, with or without a sentinel tag.
4. Female subjects of childbearing potential must have negative urine pregnancy test on entry and be using adequate contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects for whom any of the following criteria apply are not eligible for inclusion in the study:
1. Subject with acute fissure (symptoms of duration <4 weeks, no induration at edges).
2. Previous surgical treatment for anal fissure.
3. Other previous surgery involving the anal canal or perianal region.
4. Score of =30mm at baseline on the Visual Analogue Scale (VAS) for anal pain on defecation and a score of =2 on the Numeric Rating Scale for anal pain on defecation (baseline pain score is the average anal pain on defecation for the 3 defecations prior to randomisation).
5. Medical treatment of anal fissure during the past 4 weeks with gyceryl trinitrate cream (GTN cream, Rectogesic) or topical steroid containing creams (e.g. Xyloproct cream, Anusol HC etc.).
6. Subjects who have previously failed to respond to topical diltiazem therapy.
7. Subjects currently using any drugs which, in the opinion of the investigator, may influence anal sphincter tone or blood supply (e.g. a- or ß-adrenoceptor agonists [other than inhaled ß-agonists] or antagonists, sympathomimetics, anti-hypertensive agents, medical treatments for irritable bowel syndrome, PDE V inhibitors).
8. Subjects on antibiotic therapy.
9. Subjects with a history of inflammatory bowel disease.
10. Subjects with anal fissure associated with other conditions such as HIV infection, fistula-in-ano, perianal sepsis, malignancy or as a result of traumatic childbirth.
11. History or evidence on examination of pre-existing cardiac disease, including severe bradycardia, arrhythmias and conduction abnormalities.
12. Coexisting gastrointestinal disease or previous gut resection.
13. Known hypersensitivity to diltiazem.
14. Any mental or other impairment which, in the investigator’s opinion would render them unlikely to be able to comply with the requirements of the study.
15. Participation in a clinical trial within the past 3 months.
16. Previous participation in the D-CAF-06 trial.
17. Concomitant medication acting on the central nervous, cardiovascular (other than low-dose aspirin for prophylaxis) or gastrointestinal system. Xyloproct use is not permitted. Analgesics use is also not permitted during the study, although limited paracetamol use will be permitted.
18. Women who are pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method