Home » Trials » SLCTR/2016/009


Efficacy of cimetidine compared to standard therapy in reducing dapsone induced hematological adverse effects among chronic dapsone users -

SLCTR Registration Number

SLCTR/2016/009


Date of Registration

30 Mar 2016

The date of last modification

Mar 30, 2016



Application Summary


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 of 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)


Trial Details


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


Assignment

Parallel


Purpose

Prevention


Purpose


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

  1. Male and female patients aged 10-60 years
  2. Long-term dapsone therapy (>3 months) indicated [e.g. in leprosy, auto-immune blistering diseases (pemphigus vulgaris, bullous pemphigoid, dermatitis herpetiformis, linear IgA disease), vasculitis]

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

  2. Methaemoglobin level


Primary outcome(s) - Time of assessment(s)

  1. At baseline, two weeks, one month and monthly for three months

  2. At the end of 3 months


Secondary outcome

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


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Medical Research Institute on 11.2.2016 (Ref: 54/2015)


Funding source

None



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None