None listed
Conditions
Brief summary
Anal fissure is a split in the lining of the back passage and is the source of intense pain on defaecation. The underlying cause is thought to be excessive contraction and poor blood flow in the muscle (anal sphincter) that is responsible for maintaining continence. Diltiazem hydrochloride, applied locally as a cream, reduces contractions and improves blood flow in the sphincter so helping to reduce pain on defaecation and increase the chances of healing of the fissure.
Interventions
Diltiazem hydrochloride cream 2.5cm (approximately 0.5g) three times per day versus placebo 2.5cm three times per day placed around the anus for a period of up to 8 weeks.
Sponsors
S.L.A. Pharma (UK) Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Symptomatic, anal fissure (pain on or following defecation) present for >4 weeks and presenting with notable fissure-related pain. -Evidence of circumscribed fissure, with induration at the edges, with or without a sentinel tag, confirmed on physical examination. -Female subjects of childbearing potential must have negative urine pregnancy test on entry and be using adequate contraception
Exclusion criteria
Subject with acute fissure (symptoms of duration <4 weeks, no induration at edges). Previous surgical treatment for anal fissure. Other previous surgery involving the anal canal or perianal region. Score of <”Moderate” at baseline on a Likert 7-point Scale for anal pain on defaecation and a score of <4 on the Numerical Rating Scale for anal pain on defaecation (baseline pain score is the average anal pain on defaecation for the 3 defaecations prior to randomisation). Medical treatment of anal fissure during the past 4 weeks with botulinum toxin or topical steroid containing creams (e.g. Xyloproct cream, Anusol HC etc.), diltiazem or other calcium channel blocker topical or oral preparations or have used glyceryl trinitrate cream (GTN ointment, Rectogesic) for >1 week in the past 4 weeks prior to the screening visit. (NB all topical preparations to the perianal region must be stopped prior to the screening phase). Subjects who have previously failed to respond to topical diltiazem therapy. Subjects who have previously failed to respond to topical GTN therapy. Subjects currently using any drugs which, in the opinion of the investigator, may influence anal sphincter tone or blood supply (e.g. alpha- or beta-adrenoceptor agonists [other than inhaled ß-agonists] or antagonists, sympathomimetics, anti-hypertensive agents, medical treatments for irritable bowel syndrome, phosphodiesterase-5 inhibitors (PDE V inhibitors) Subjects on antibiotic therapy. Subjects with a history of inflammatory bowel disease. Subjects with anal fissure associated with other conditions such as human immunodeficientcy virus (HIV) infection, fistula-in-ano, perianal sepsis, malignancy or as a result of traumatic childbirth. History or evidence on examination of pre-existing cardiac disease, including severe bradycardia, arrhythmias and conduction abnormalities. Coexisting gastrointestinal disease or previous gut resection. Known hypersensitivity to diltiazem.
Outcome results
None listed