LymphedemaPhase 3LeDoxy-IndiaNCT02929121
A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in India
A Phase 3 study testing Doxycycline in people with Lymphedema and Lymphatic Filariasis, run by The Task Force for Global Health at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Lymphatic Filariasis, Filariasis
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2019to 18 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients eligible for the trial must comply with all of the following at randomization:
- 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
- Able to give informed consent to participate in the trial (forms to be attached)
- Resident in endemic area for five years or more
- Body weight >40 kg
- Lymphedema of a limb Grade 1-6 measured on a 7-point scale. (Appendix 1 for explanation of the grading system (Dreyer G et al. 2002).
Show all 10Show fewer
- Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
- No evidence of severe or systemic comorbidities except for features of filarial disease
- Normal laboratory profile (Appendix 3 investigations and the maximum or minimum limits in the case of hematological abnormalities - Site Specific)
- Consent to storage of blood samples for study
Who cannot join
- Patients are ineligible to participate in the trial, if patients have any of the following:
- No lymphedema or lymphedema stage 7
- Age < 14 years or > 65 years
- Body weight < 40 kg
- Pregnant or breastfeeding women
- 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)
Show all 10Show fewer
- Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease
- Alcohol or drug abuse
- History of adverse reactions to doxycycline or other tetracyclines
- Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator
Trial locations and contacts
1 site in 1 country.
India1 site
Filariasis Research Unit Govt. T. D. Medical College Hospital
Alappuzha, Kerala, 688005
About this study
Official title: A Multi-center, Double-blind, Randomized, 24-month Study, to Compare the Efficacy of Doxycycline Once Daily for 6 Weeks Versus Placebo in Improving Filarial Lymphedema Independent of Active Filarial Infection
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.
Read the detailed description
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.
- Conditions
- Lymphedema, Lymphatic Filariasis, Filariasis
- Being tested
- Doxycycline, Placebo
- Keywords
- Lymphedema, Lymphatic Filariasis, Filariasis, Doxycycline
- Medical subject headings
- Lymphedema, Elephantiasis, Filarial, Filariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxycycline hyclate
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)
PlaceboDrug
Once daily tablet for 6 weeks: matching tablets containing no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | 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). Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lymphadema Grade
Change in lymphedema grade at 24 months compared to baseline
Measured: 24 months
Secondary outcomes (1)
Change in number of acute attacks
Change in number of acute attacks
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start15 Jan 2019
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Task Force for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Eric Ottesen, The Task Force for Global Health
- Investigators
- Eric Ottesen, MD, Principal investigator, The Task Force for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929121
- Sponsor's protocol ID
- LeDoxy2015_India
- Acronym
- LeDoxy-India
- Status last verified
- Jun 2021
- First submitted
- 7 Oct 2016
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shenoy RK, Kumaraswami V, Suma TK, Rajan K, Radhakuttyamma G. A double-blind, placebo-controlled study of the efficacy of oral penicillin, diethylcarbamazine or local treatment of the affected limb in preventing acute adenolymphangitis in lymphoedema caused by brugian filariasis. Ann Trop Med Parasitol. 1999 Jun;93(4):367-77. doi: 10.1080/00034989958366.
PubMed 10656038Mand S, Debrah AY, Klarmann U, Batsa L, Marfo-Debrekyei Y, Kwarteng A, Specht S, Belda-Domene A, Fimmers R, Taylor M, Adjei O, Hoerauf A. Doxycycline improves filarial lymphedema independent of active filarial infection: a randomized controlled trial. Clin Infect Dis. 2012 Sep;55(5):621-30. doi: 10.1093/cid/cis486. Epub 2012 May 18.
PubMed 22610930Dreyer G, Dreyer P, Noroes J. [Recommendations for the treatment of bancroftian filariasis in symptomless and diseased patients]. Rev Soc Bras Med Trop. 2002 Jan-Feb;35(1):43-50. doi: 10.1590/s0037-86822002000100009. Portuguese.
PubMed 11873261Horton J, Klarmann-Schulz U, Stephens M, Budge PJ, Coulibaly Y, Debrah A, Debrah LB, Krishnasastry S, Mwingira U, Ngenya A, Wanji S, Weerasooriya M, Yahathugoda C, Kroidl I, Deathe D, Majewski A, Sullivan S, Mackenzie C, Nutman TB, Shott JP, Weil G, Ottesen E, Hoerauf A. The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis. Parasit Vectors. 2020 Mar 30;13(1):155. doi: 10.1186/s13071-020-04024-2.
PubMed 32228663
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, 24-month Study, to Compare the Efficacy of Doxycycline Once Daily for 6 Weeks Versus Placebo in Improving Filarial Lymphedema Independent of Active Filarial Infection
- ClinicalTrials.gov ID
- NCT02929121
- Acronym / sponsor ID
- LeDoxy-India / LeDoxy2015_India
- Conditions
- Lymphedema, Lymphatic Filariasis, Filariasis
- Keywords
- Lymphedema, Lymphatic Filariasis, Filariasis, Doxycycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- The Task Force for Global HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: DoxycyclineThe 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). |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Able to give informed consent to participate in the trial (forms to be attached)
- Resident in endemic area for five years or more
- Body weight >40 kg
- Lymphedema of a limb Grade 1-6 measured on a 7-point scale. (Appendix 1 for explanation of the grading system (Dreyer G et al. 2002).
Key exclusion criteria (10 listed)
- Patients are ineligible to participate in the trial, if patients have any of the following:
- No lymphedema or lymphedema stage 7
- Age < 14 years or > 65 years
- Body weight < 40 kg
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Doxycycline hyclateOnce 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) | Drug | Doxycycline |
| PlaceboOnce daily tablet for 6 weeks: matching tablets containing no active ingredients | Drug | Placebo |
Primary outcome
Change in Lymphadema Grade
Time frame: 24 months
Change in lymphedema grade at 24 months compared to baseline
1 secondary outcome
Change in number of acute attacks
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Results publication: PubMed 10656038Shenoy RK, Kumaraswami V, Suma TK, Rajan K, Radhakuttyamma G. A double-blind, placebo-controlled study of the efficacy of oral penicillin, diethylcarbamazine or local treatment of the affected limb in preventing acute adenolymphangitis in lymphoedema caused by brugian filariasis. Ann Trop Med Parasitol. 1999 Jun;93(4):367-77. doi: 10.1080/00034989958366.
- Results publication: PubMed 22610930Mand S, Debrah AY, Klarmann U, Batsa L, Marfo-Debrekyei Y, Kwarteng A, Specht S, Belda-Domene A, Fimmers R, Taylor M, Adjei O, Hoerauf A. Doxycycline improves filarial lymphedema independent of active filarial infection: a randomized controlled trial. Clin Infect Dis. 2012 Sep;55(5):621-30. doi: 10.1093/cid/cis486. Epub 2012 May 18.
- Results publication: PubMed 11873261Dreyer G, Dreyer P, Noroes J. [Recommendations for the treatment of bancroftian filariasis in symptomless and diseased patients]. Rev Soc Bras Med Trop. 2002 Jan-Feb;35(1):43-50. doi: 10.1590/s0037-86822002000100009. Portuguese.
- Derived from this study: PubMed 32228663Horton J, Klarmann-Schulz U, Stephens M, Budge PJ, Coulibaly Y, Debrah A, Debrah LB, Krishnasastry S, Mwingira U, Ngenya A, Wanji S, Weerasooriya M, Yahathugoda C, Kroidl I, Deathe D, Majewski A, Sullivan S, Mackenzie C, Nutman TB, Shott JP, Weil G, Ottesen E, Hoerauf A. The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis. Parasit Vectors. 2020 Mar 30;13(1):155. doi: 10.1186/s13071-020-04024-2.
- The Task Force for Global HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Ottesen, MD principal investigator
The Task Force for Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline in people with Lymphedema and Lymphatic Filariasis, run by The Task Force for Global Health at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lymphadema Grade (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929121, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.