Home » Trials » SLCTR/2016/009
Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users
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SLCTR Registration Number
SLCTR/2016/009
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users
Public Title of Trial
Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users
Disease or Health Condition(s) Studied
Haematological adverse effects in chronic dapsone use
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
1111-1177-7749
Any other number(s) assigned to the trial and issuing authority
54/2015 (ERC-Medical Research Institute)
What is the research question being addressed?
What is the effectiveness of cimetedine compared to standard therapy in reducing haematological adverse effects of dapsone among chronic dapsone users?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study setting
1.Lady Ridgeway Hospital (children)
2. National Hospital Sri Lanka (Adults)
3. Teaching hospital Colombo South (Adults)
4.Teaching Hospital Karapitiya (Adults)
Participant Recruitment:
Consenting patients attending outpatient dermatology clinics will be allocated in to two arms using simple randomization
1.Intervention arm
Participants will receive cimetidine according to the following regimen
Children (10 - 12 years of age) 25mg/kg/day given orally in two divided doses (bd) for a total of 4 weeks
Adults and children >12 years of age 400 mg orally twice a day (bd) for a total of 4 weeks
Standard therapy of dapsone with or without multidrug therapy will be administered according to guidelines.
2.Control arm
Standard therapy of dapsone with or without multidrug therapy will be administered according to guidelines
Inclusion criteria
Exclusion criteria
1.Diagnosed liver disease and/or any degree of elevated AST/ALT at
recruitment
2.Diagnosed renal disease and/or any degree of elevated serum creatinine at recruitment
3.Haemoglobin <10g/dl
4. Cytopaenias and/or other haematological diseases (lymphoproliferative/myeloproliferative)
5. Diabetes Mellitus
6. Epilepsy
7. Cardiac disease (NYHA grade 2 and above)
8. Diagnosed psychiatric illness
9. Prisoners and other institutionalized patients
10. Patients currently on any long term medications
Primary outcome(s)
|
1.
Reduction of haemolysis using • Haemoglobin • Reticulocyte count • Blood picture |
[ At baseline, two weeks, one month and monthly for three months ] |
|
2.
Methaemoglobin level |
[ At the end of 3 months ] |
Secondary outcome(s)
|
1.
Adverse effects related to cimetidine therapy assessed using a symptom diary, patient history, examination and investigations. Common side effects 1. Diarrhea 2. Headache/Dizziness Rare side effects 3. Rash (EM.TEN) 4. Hepatitis/cholestatic jaundice 5. Bradycardia 6. Psychiatric reactions (depression, hallucinations) 7. Blood disorders (leucopenia, thrombocytopenia, pancytopenia) Very rare side effects 8. Pancreatitis 9. Vasculitis 10. Alopecia 11. Gynaecomastia/ impotence |
[ At two weeks, one month and monthly for three months ] |
Target number/sample size
50 (25 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-04-01
Anticipated end date
2017-01-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-11-11
Approval number
54/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Medical Research Institute, Ministry of Health |
| Institutional Address: | P.O. Box 527, Dr Danister De Silva Mawatha (Baseline Road), Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2693532 (Extension: 353) |
| Email: | erc_mri2016@hotmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. H.S. Sudusinghe
Senior Registrar in Dermatology
Lady Ridgeway Hospital,
Dr. Danister De Silva Mawatha,
Colombo 08, Sri Lanka.
Tel: 0112693711
Mob: 0713384821
hssudusinghe@gmail.com
Contact Person for Public Queries
Prof. Jayamini Seneviratne
Consultant Dermatologist
Lady Ridgeway Hospital,
Dr. Danister De Silva Mawatha,
Colombo 08, Sri Lanka.
Tel: 0112693711
Mob: 0777383759
lrhderma@gmail.com
Primary study sponsor/organization
Lady Ridgeway Hospital
Dr. Danister De Silva Mawatha,
Colombo 08, Sri Lanka.
Tel: 0112693711
hiru@lrh-hospital.health.gov.lk
http://www.lrh-hospital.health.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
