Clinical trial to show the safety and efficacy of Diltiazem hydrochloride cream used for treatment of anal fissure.

Phase 1

• Conditions: Symptomatic relief of pain related to anal fissure (AF).; MedDRA version: 14.0Level: PTClassification code 10002153Term: Anal fissureSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2008-005172-26-SK
• Lead Sponsor: S.L.A. Pharma (UK) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-18
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

- Must give written informed consent.
- Male or female subjects = 18 years of age.
- Subjects with at least a 4 week history of painful AF prior to screening, where AF-related pain associated with, or following, defaecation is experienced at least twice a week for the 4 weeks prior to screening with an average of = 3 on an 11-point NRS.
- Subjects with an average of =4, on an 11-point NRS, during the screening phase, for worst anal pain associated with, or following, defaecation for the most recent three days on which the subject has defaecated.
- Subjects with evidence of a circumscribed fissure, with induration at the edges.
- Willing to stop all other concomitant topical preparations applied perianally prior to commencing study treatment and throughout the study.
- Willingness and ability to use the IVRS diary.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

- Subjects unwilling to have examination of AF.
- Subjects with acute” AF (i.e. duration of symptoms less than 4 weeks prior to screening, and/or no induration of fissure edges).
- More than one AF.
- Subjects who have had lateral sphincterotomy or anal stretch or other previous
surgery involving the anal canal or perianal region.
- Subjects who have had subfissure injection of botulinum toxin in the 3 months prior to screening, or have used GTN ointment for >1 week in the 4 weeks prior to the screening visit.
- Subjects with AF associated with other conditions (drug-induced [e.g. nicorandil], trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or
malignancy).
- Subjects with cardiovascular disease (including those diagnosed by screening ECG): history of reduced left ventricular function, bradycardia, 1st degree AV block or
prolonged PR interval (>0.2 seconds/ >200 milliseconds).
- Subjects with known hypersensitivity to diltiazem.
- Subjects who have previously received therapy with diltiazem hydrochloride cream or other topical calcium channel blockers.
- Subjects taking prohibited medications.
- Subjects who have taken experimental agents must have been discontinued at least 8 weeks prior to screening, or for a period equivalent to 5 half-lives (t1/2) of the agent (whichever is longer);
- Subjects who have or who have undergone the following gastrointestinal disorders and procedures:
- Inflammatory bowel disease.
- Chronic faecal incontinence.
- History of chronic constipation or constipation in the 4 weeks prior to the screening phase (defined as 2 or less defaecations per week; associated with straining/passage of hard stools).
- Anal abscess.
- A history of radiation therapy to the pelvis.
- Fixed anal stenosis/fibrosis.
- Subjects with a history of neoplastic disease within 5 years (except for basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin).
- Subjects with a clinically significant history of renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or haematological illness.
- Subjects with any laboratory test/ECG results considered clinically significant at screening.
- Subjects with planned elective or other treatment requiring hospitalisation, during the study, booked before entry into the study
- Subjects who will be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
- Women of childbearing potential unless surgically sterile or using adequate contraception (either intrauterine device [IUD], oral or depot contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 1 month after the last application of study drug. Women using oral contraception must have started using it at least 2 months prior to enrolment.
- Women who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified