A Phase 3 interventional study of Doxycycline and Placebo in Lymphedema, Lymphatic Filariasis and Filariasis, sponsored by The Task Force for Global Health. Completed at 1 site in Sri Lanka. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by The Task Force for Global Health · Phase 3, Interventional, and Treatment
Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema.
In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.
This (LEDOXY) trial is designed as a randomized, controlled, observer-, provider- and patient-blinded multicenter superiority trial with two parallel groups and a primary endpoint of change in grade of lymphedema at 24 months. The population will be stratified according to the Grade (Early Grade 1-3; Late Grade 4-6). Randomization will be performed as block randomization within each center in blocks of (N=4-10) for each of the groups (Early and Late).
The effect of a 6-week course doxycycline on lymphedema without active filarial infection has been demonstrated in a single setting in Africa (Ghana). In order to expand the benefits of this observation, similar studies need to be carried out in other endemic settings. Lymphatic filariasis is endemic in many countries of Africa and Asia that are yet to implement morbidity management programmes. In addition, the components of the proposed hygiene package are likely to vary depending on the availability of material and human resources. The conduct of this trial as a multi-center study will not only allow the evaluation of the efficacy of the drug in a variety of settings but also facilitate its rapid adoption by the respective control programmes of endemic countries, if proven to be useful.
The choice of study sites in endemic countries has been made based on the availability of a) adequate numbers of patients with various grades of lymphedema and b) clinical trial teams familiar with lymphedema management procedures and past experience with similar trials.
All screened patients will be enrolled into a programme of hygiene (described below) and will be required to demonstrate ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment. Eligible patients will be randomized to receive either daily doxycycline or placebo. Doxycycline and placebo will be provided by Medopharm (India). Re-labeling and packaging of the drug and the placebo will be done by Piramal Healthcare, Morpeth, UK Additionally, after un-blinding and data analysis, the placebo group will be offered doxycycline treatment if the intervention proves to be more effective in ameliorating LE.
Both doxycycline and placebo will be administered under supervision (directly observed treatment) for 6 weeks. The first dose of doxycycline (two 100 mg tablets for those over 50kg body weight and one 100 mg tablets for those between 40 and 50 kg body weight) or placebo will be given after all the investigations have been completed and informed consent has been obtained and the patient has been initiated into the programme of basic hygiene. Patients will be encouraged to eat before swallowing the tablets whole with a glass of water. Vomited doses will be replaced.
Ideally, patients will be required to come every day to the closest community health center to take their drugs under supervision. Subjects living in villages at a distance from any health center will be treated by the community health care provider or the local caregiver living in this village who will be informed and trained in the possible adverse events related to the drug.
Since some study sites may be village based without a health centre, patients may be treated in their village and required to attend daily at a fixed meeting point. The trial clinician and the research team with the help of trained community health workers will normally administer the treatment. Patients should come to the clinic every week with the patient and collect the drugs for one week. The provider will keep a diary where he or she will mark down the time of intake of the drug. A health worker may make surprise checks at the patient's residence by looking at the diary and also by counting the remaining drugs to estimate compliance.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 219 is below the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →The Task Force for Global Health is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Compared within Elephantiasis, Filarial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphedema. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients eligible for the trial must comply with all of the following at randomization:
Exclusion Criteria:
Patients are ineligible to participate in the trial, if patients have any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Doxycycline treated group will enroll 125 participants. 100 patients with Grades 1-3 lymphedema per study site (based on end point and duration) and up to 25 patients with grade 4-6 lymphedema/per study site. Each patient will receive Doxycycline hyclate 200 mg per day x 6 weeks for patients \>50 kg or 100 mg per day for patients \<50 kg).
Drug: Doxycycline
The Placebo treated group will enroll 125 participants. 100 patients with Grades 1-3 lymphedema per study site (based on end point and duration) and up to 25 patients with grade 4-6 lymphedema/per study site. Each patient will receive matching tablets containing no active ingredients.
Drug: Placebo
Once daily tablet for 6 weeks: Doxycycline hyclate 200 mg per day x 6 weeks for patients \>50 kg or 100 mg per day for patients \<50 kg)
Also known as: Doxycycline hyclate
Once daily tablet for 6 weeks: matching tablets containing no active ingredients
Change in Lymphadema Grade
Change in lymphedema grade at 24 months compared to baseline
Time frame: 24 Months
Change in number of acute attacks
Change in number of acute attacks
Time frame: 24 Months
Plan to share: No
Ran from Feb 2018 to primary completion in Jun 2020, 27 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Doxycycline
The Task Force for Global Health