Leishmaniasis, CutaneousNCT00480883
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
A study testing meglumine antimoniate, allopurinol and meglumine antimoniate in people with Leishmaniasis, Cutaneous, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- meglumine antimoniate, allopurinol and meglumine antimoniate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 50 years old.
- Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.
- Positive parasitological diagnosis for cutaneous leishmaniasis.
- Patients that voluntarily accept to participate in the study and sign the informed consent.
- Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).
- Acceptation of not using any other treatment for cutaneous leishmaniasis while in the study.
Who cannot join
- Pregnant women.
- Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.
- Diffuse cutaneous leishmaniasis.
- Visceral leishmaniasis.
- Complete or incomplete treatment with antimony compounds in the last three months.
- Patients with history of hepatic, renal, or cardiovascular disease.
- Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Military Hospital
Kharian Cantonment, Punjab Province, 74400
About this study
Official title: Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- meglumine antimoniate, allopurinol, meglumine antimoniate
- Keywords
- cutaneous leishmaniasis of the old world
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meglumine antimoniate, allopurinolDrug
first drug in injectable, second is in tablet form.
meglumine antimoniateDrug
injectable 20 mg/kg/day/intramuscular for 21 days.
meglumine antimoniate, allopurinolDrug
injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | injection meglumine antimoniate 20 mg/kg/day/intramuscular for 21 days. Receives: Drug: meglumine antimoniate |
| 2 | Experimental | injection meglumine antimoniate 10 mg/kg/day/intramuscular plus tablet allopurinol 1200 mg/day/6hourly divided doses. Receives: Drug: meglumine antimoniate, allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical healing of lesions.
Measured: 3 months
Secondary outcomes (1)
improvement of more than 50% in lesion size
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Investigators
- AMER EJAZ, FCPS, Principal investigator, Combined Military Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480883
- Sponsor's protocol ID
- 001
- Status last verified
- May 2008
- First submitted
- 29 May 2007
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Momeni AZ, Reiszadae MR, Aminjavaheri M. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low-dose meglumine antimoniate. Int J Dermatol. 2002 Jul;41(7):441-3. doi: 10.1046/j.1365-4362.2002.01527.x.
PubMed 12121563
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day
- ClinicalTrials.gov ID
- NCT00480883
- Acronym / sponsor ID
- 001
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- cutaneous leishmaniasis of the old world
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 May 2007 (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.
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: meglumine antimoniateinjection meglumine antimoniate 20 mg/kg/day/intramuscular for 21 days. |
| 2 | Experimental | Drug: meglumine antimoniate, allopurinolinjection meglumine antimoniate 10 mg/kg/day/intramuscular plus tablet allopurinol 1200 mg/day/6hourly divided doses. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women between 18 and 50 years old.
- Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.
- Positive parasitological diagnosis for cutaneous leishmaniasis.
- Patients that voluntarily accept to participate in the study and sign the informed consent.
- Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).
Key exclusion criteria (7 listed)
- Pregnant women.
- Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.
- Diffuse cutaneous leishmaniasis.
- Visceral leishmaniasis.
- Complete or incomplete treatment with antimony compounds in the last three months.
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 |
|---|---|---|
| meglumine antimoniate, allopurinolfirst drug in injectable, second is in tablet form. | Drug | 2 |
| meglumine antimoniateinjectable 20 mg/kg/day/intramuscular for 21 days. | Drug | 1 |
| meglumine antimoniate, allopurinolinjectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days. | Drug | 2 |
Primary outcome
clinical healing of lesions.
Time frame: 3 months
1 secondary outcome
improvement of more than 50% in lesion size
Time frame: 3 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 2 Jun 2010.
- Background: PubMed 12121563Momeni AZ, Reiszadae MR, Aminjavaheri M. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low-dose meglumine antimoniate. Int J Dermatol. 2002 Jul;41(7):441-3. doi: 10.1046/j.1365-4362.2002.01527.x.
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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.
AMER EJAZ, FCPS principal investigator
Combined Military Hospital, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meglumine antimoniate, allopurinol and meglumine antimoniate in people with Leishmaniasis, Cutaneous, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 6 inclusion and 7 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 2 Jun 2010. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
clinical healing of lesions. (time frame: 3 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 NCT00480883, which also lists 1 linked publication.
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 2 Jun 2010.