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Trial registered on ANZCTR


Registration number
ACTRN12607000616471
Ethics application status
Approved
Date submitted
19/10/2007
Date registered
29/11/2007
Date last updated
30/03/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind, placebo controlled study of diltiazem hydrocholoride 2% cream in the treatment of fissure in ano.
Scientific title
A double blind, placebo controlled study of diltiazem hydrocholoride 2% cream in the treatment of fissure in ano.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Fissure 2485 0
A study to determine the effect of diltiazem hydrochloride cream in patients with anal fissure 2502 0
Condition category
Condition code
Oral and Gastrointestinal 2606 2606 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2237 0
Treatment: Drugs
Comparator / control treatment
Placebo - cream base as for active composed of liquid paraffin, cetomacragol emulsifying wax, glyceryl monostearate, propylene glycol, phenoxyethanol and water
Control group
Placebo

Outcomes
Primary outcome [1] 3494 0
This study seeks to address the following question:
Does topical application of diltiazem hydrochloride 2% cream provide greater relief of pain on defaecation than placebo in subjects with chronic anal fissure (as measured on a Likert scale)
Timepoint [1] 3494 0
Randomisation
Week 2, Week 4 & Week 8
Secondary outcome [1] 5831 0
Numbers of subjects achieving predetermined changes in Likert score for pain on defaecation from baseline to Week 4.
Health outcome measure at 8 weeks compared to baseline
Fissure healing status
Timepoint [1] 5831 0
Weeks 4 & 8

Eligibility
Key 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
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2739 0
Commercial sector/Industry
Name [1] 2739 0
S.L.A. Pharma (UK) Ltd
Country [1] 2739 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
S.L.A. Pharma (UK) Ltd
Address
Elite House
Hill Farm Industrial Estate
Leavesden
Watford
WD25 7SA
Country
United Kingdom
Secondary sponsor category [1] 2548 0
Commercial sector/Industry
Name [1] 2548 0
S.L.A. Pharma (UK) Ltd
Address [1] 2548 0
Elite House
Hill Farm Industrial Estate
Leavesden
Watford
WD25 7SA
Country [1] 2548 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4753 0
St Vincent's Hospital, Sydney HREC
Ethics committee address [1] 4753 0
ABN 77 054 038 872
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 4753 0
Australia
Date submitted for ethics approval [1] 4753 0
10/10/2007
Approval date [1] 4753 0
13/11/2007
Ethics approval number [1] 4753 0
07/SVH/58

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28134 0
Address 28134 0
Country 28134 0
Phone 28134 0
Fax 28134 0
Email 28134 0
Contact person for public queries
Name 11291 0
Dr Darren Gold
Address 11291 0
Surgical Professorial Unit
St Vincent's Hospital
Victoria St
Darlinghurst NSW 2010
Country 11291 0
Australia
Phone 11291 0
+61 2 83821111
Fax 11291 0
+61 2 83822794
Email 11291 0
[email protected]
Contact person for scientific queries
Name 2219 0
Dr Chris Jordan
Address 2219 0
S.L.A. Pharma (UK)
Elite Hourse
Hill Farm Industrial Estate
Leavesden
Watford WD25 7SA
Country 2219 0
United Kingdom
Phone 2219 0
+44 1923681001
Fax 2219 0
Email 2219 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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