Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201304000524290 Date of Approval: 18/03/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title To determine if 0.2% topical Nifedipine has better healing rates than 0.2% topical Glyceryl Trinitrate in the treatment of Chronic Anal Fissures
Official scientific title A RANDOMISED CLINICAL TRIAL COMPARING TOPICAL 0.2% NIFEDIPINE VS. 0.2% GLYCERYL TRINITRATE FOR THE TREATMENT OF CHRONIC ANAL FISSURES
Brief summary describing the background and objectives of the trial Chemical sphincterotomy is the first line in management of chronic anal fissures and 0.2% Glyceryl Trinitrate has been the drug of choice. However, it has a healing rate of 58% and high incidence of headache leading to poor compliance. Topical nifedipine has been shown to have a higher healing rate with few side effects. It is also more affordable. Objectives: To evaluate effectiveness of a 0.2% topical nifedipine vs 0.2% GTN in the treatment of chronic anal fissure
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic Anal Fissure,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2013
Actual trial start date 09/12/2013
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated randomization table by an independent statistician will be placed in the Simple randomisation using a radomisation table created by a computer software program Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 0.2% Nifedipine gel q12hourly 8 weeks epithelialization or formation of a scar over fissure 33
Control Group Group B 0.2% glyceryl trinitrate q12hourly 8 weeks Epithelialization or formation of a scar over fissure 38 Active-Treatment of Control Group
Experimental Group Group A 0.2% Nifedipine gel q12hourly 8 weeks epithelialization or formation of a scar over fissure 37 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age : 18 years or older 2. History of anal pain on defecation for at least 6 weeks ± 3. Presence of any 1 of the following: -Sentinel pile -Hypertrophied apical papilla or -Visible fibres of IAS 1.Fissures not consistent with above diagnostic criteria 2.Previous surgery for anal fissure 3.Fissures secondary to other diseases e.g. Crohn¿s disease, ulcerative colitis, malignancies, tuberculosis etc. 4.Associated complications warranting surgery (abscess, fistula etc) 5.Coexistent medical conditions using calcium channel blocker and oral, sublingual or transdermal nitrates 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/03/2013 Ethical and Scientific Review Committee at the Aga Khan University Hospital, Nairobi
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The overall healing rate of Nifedipine vs GTN-treated patients with chronic anal fissure 8 weeks
Secondary Outcome What proportion of participants have epithelialization or formation of a scar by 2, 4, 6 and 8 weeks 2 weeks 4 weeks 6 weeks 8 weeks
Secondary Outcome The resolution of pain 2 weeks 4 weeks 6 weeks 8 weeks Using a Visual Analog Scale
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital (Nairobi) 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Board of Postgraduate Medical Education, Aga Khan University Hospital 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Board of Postgraduate Medical Education, Aga Khan University Hospital 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr Abdulkarim Abdallah 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
Professor Hassan Saidi 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
Professor Ronald Wasike 3rd Parklands Avenue P. O. Box 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Siboe marxiboy@gmail.com +254722538322 P. O. Box 73946
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Surgeon
Role Name Email Phone Street address
Public Enquiries Mark Siboe marxiboy@gmail.com +254722538322 P. O. Box 73946
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Surgeon
Role Name Email Phone Street address
Scientific Enquiries Mark Siboe marxiboy@gmail.com +254722538322 P. O. Box 73946
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Surgeon
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information