A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka
- Conditions
- Chronic Lymphoedema due to Lymphatic Filariasis
- Registration Number
- SLCTR/2017/021
- Lead Sponsor
- Task Force for Global Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Age > 14 years and <65 years, male or non-pregnant women of childbearing-potential using an approved, effective method of contraception before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
2. Able to give informed consent to participate in the trial
3. Resident in endemic area for five years or more
4. Body weight >40 kg
5. Lymphedema of a limb Grade 1-6 measured on a 7-point scale (Dreyer G et al. 2002).
6. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
7. No evidence of severe or systemic co-morbidities except for features of filarial disease
8. Normal laboratory profile
9. Consent to storage of blood samples for study
1. No lymphedema or lymphedema stage 7
2. Age < 14 years or > 65 years
3. Body weight < 40 kg
4. Pregnant or breastfeeding women
5. Women of childbearing potential not using an agreed method of contraception. (A pregnancy test will be conducted as part of the screening process to exclude pregnancy and repeated at 3 and 8 weeks. In addition, women of childbearing potential will be counseled against pregnancy during the treatment period)
6. Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease
7. Alcohol or drug abuse
8. History of adverse reactions to doxycycline or other tetracyclines
9. Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator
10. Chronic headache and current headache
11. Persons who are currently taking doxycycline for other indications
12. Lymphedema due to post-radiation, post-surgical and primary (congenital) lymphedema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method