A comparative study of the efficacy of combination therapy with oral omeprazole and low dose of systemic meglumine antimoniate versus the standard dose of systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis
| ISRCTN | ISRCTN32701387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32701387 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/03/2006
- Registration date
- 15/06/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohammad Ali Nilfroushzadeh
Scientific
Scientific
Khoram Street
Skin Diseases and Leishmaniasis Research Center
Isfahan
81876-98191
Iran
| Phone | +98 (0)31 13373736 |
|---|---|
| nilfroushzadeh@mui.ac.ir |
Study information
| Study design | Double-blind randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The effect of oral omeprazole and low dose systemic meglumine antimoniate (MA) is more than the standard dose of systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis. |
| Ethics approval(s) | The research has been ethically approved by the Ethical committee of the Skin Diseases and Leishmaniasis Research Center (SDLRC) on 11/02/2003, reference number: 85318 |
| Health condition(s) or problem(s) studied | Cutaneous leishmaniasis |
| Intervention | Group 1 was treated with intramuscular 60 mg/kg/day glucantime (MA) and placebo for three weeks. Group 2 was treated with intramuscular 30 mg/kg/day glucantime and 40 mg of the oral omeprazole for three weeks. Group 3 was treated with intramuscular 30 mg/kg/day glucantime and oral placebo for three weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omeprazole, meglumine antimoniate (glucantime) |
| Primary outcome measure | Healing rate during the course of treatment was more in the groups treated with standard dose glucantime and placebo and low dose glucantime and omeprazole than the group treated with low dose glucantime and placebo (P <0.05). |
| Secondary outcome measures | Combination therapy with oral omeprazole and low dose of glucantime can be used as alternative treatment for leishmaniasis especially in patients with history of cardiac, renal, and hepatic disease. Patients with cardiac diseases were excluded because of some cardiac effects of the glucantime. However, glucantime is not absolutely contraindicated in patients with cardiac diseases and it can be prescribed with ECG monitoring. The study showed that the use of omeprazole as adjuvant therapy will decrease the dose of glucantime for the treatment of cutaneous leishmaniasis and therefore possibly decrease the risk of cardiac events attributed to the use of full dose of glucantime. |
| Overall study start date | 28/06/2004 |
| Completion date | 28/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | All of the patients had positive smear for leishman body and have not received any topical or systemic therapy for leishmaniasis. The age of patients was between 7-70 years old. |
| Key exclusion criteria | Patients who were pregnant or lactating and patients with history of cardiac, renal, hepatic diseases or patients with any contraindication for treatment were excluded. |
| Date of first enrolment | 28/06/2004 |
| Date of final enrolment | 28/06/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
Khoram Street
Isfahan
81876-98191
Iran
81876-98191
Iran
Sponsor information
Skin Diseases and Leishmaniasis Research Center (SDLRC) (Iran)
Research organisation
Research organisation
Khoram Street
Isfahan
81876-98191
Iran
| Phone | +98 (0)31 13373736 |
|---|---|
| sdlrc@mui.ac.ir | |
"ROR" |
https://ror.org/04waqzz56 |
Funders
Funder type
Research organisation
Skin Diseases and Leishmaniasis Research Centre (SDLRC) at the University of Iran (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
