Borderline Lepromatous LeprosyPhase 4NCT01290744
Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
A Phase 4 study testing Clofazimine in people with Borderline Lepromatous Leprosy and Lepromatous Leprosy, run by Paul Saunderson at 1 site in Philippines.
Trial summary
This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Borderline Lepromatous Leprosy, Lepromatous Leprosy
- What is being tested?
- Clofazimine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2010to Mar 2015
- Phase
- Phase 4
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 to 70 years of age
- MB leprosy
- Pretreatment BI of 4 or more at any site
- Consent
Who cannot join
- Presence of another serious illness
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Additional Clofazimine on ENL Reactions in Leprosy
This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.
Read the detailed description
Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.
- Being tested
- Clofazimine, Placebo
- Keywords
- leprosy, ENL, clofazimine
- Medical subject headings
- Leprosy, Lepromatous, Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofazimineDrug
Also called Lamprene
Clofazimine 100mg daily for 12 months after completion of MDT.
PlaceboDrug
Also called Vitamin capsule
Daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | These patients will receive placebo for 12 months after completion of MDT. Receives: Drug: Placebo |
| Clofazimine for 12 months after MDT | Experimental | Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT. Receives: Drug: Clofazimine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ENL reactions
The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
Measured: 2 years of follow-up
Secondary outcomes (1)
Severity of ENL reactions
The hypothesis is that additional clofazimine will reduce severity of ENL reactions, as well as incidence. Severity will be monitored by three indicators: 1. a rather crude clinical score (mild, moderate or severe), 2. the total dose of prednisolone given to treat ENL reactions, 3. the total duration of ENL symptoms.
Measured: 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Lepromatous LeprosyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Saunderson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Saunderson, Leonard Wood Memorial
- Investigators
- Marivic Balagon, MD, Principal investigator, LWM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290744
- Sponsor's protocol ID
- LWM-2010-ENL
- Status last verified
- Jun 2015
- First submitted
- 2 Feb 2011
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Additional Clofazimine on ENL Reactions in Leprosy
- ClinicalTrials.gov ID
- NCT01290744
- Acronym / sponsor ID
- LWM-2010-ENL
- Keywords
- leprosy, ENL, clofazimine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Paul SaundersonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Feb 2011 (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.
This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.
Detailed description
Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboThese patients will receive placebo for 12 months after completion of MDT. |
| Clofazimine for 12 months after MDT | Experimental | Drug: ClofaziminePatients will be given clofazimine (100mg daily) for 12 months after completion of MDT. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 15 to 70 years of age
- MB leprosy
- Pretreatment BI of 4 or more at any site
- Consent
Key exclusion criteria (2 listed)
- Presence of another serious illness
- Refusal of informed consent
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 |
|---|---|---|
| ClofazimineAlso: LampreneClofazimine 100mg daily for 12 months after completion of MDT. | Drug | Clofazimine for 12 months after MDT |
| PlaceboAlso: Vitamin capsuleDaily for 12 months | Drug | Placebo group |
Primary outcome
Incidence of ENL reactions
Time frame: 2 years of follow-up
The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
1 secondary outcome
Severity of ENL reactions
Time frame: 2 years of follow-up
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 4 Jun 2015.
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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.
Marivic Balagon, MD principal investigator
LWM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clofazimine in people with Borderline Lepromatous Leprosy and Lepromatous Leprosy, run by Paul Saunderson at 1 site in Philippines.
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 4 inclusion and 2 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 4 Jun 2015. 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 Philippines. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of ENL reactions (time frame: 2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2015.