Condition category
Skin and Connective Tissue Diseases
Date applied
05/03/2006
Date assigned
15/06/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohammad Ali Nilfroushzadeh

ORCID ID

Contact details

Khoram Street
Skin Diseases and Leishmaniasis Research Center
Isfahan
81876-98191
Iran
+98 (0)31 13373736
nilfroushzadeh@mui.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Double-blind randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Omeprazole, meglumine antimoniate (glucantime)

Primary outcome measures

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 trial start date

28/06/2004

Overall trial end date

28/06/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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.

Recruitment start date

28/06/2004

Recruitment end date

28/06/2005

Locations

Countries of recruitment

Iran

Trial participating centre

Khoram Street
Isfahan
81876-98191
Iran

Sponsor information

Organisation

Skin Diseases and Leishmaniasis Research Center (SDLRC) (Iran)

Sponsor details

Khoram Street
Isfahan
81876-98191
Iran
+98 (0)31 13373736
sdlrc@mui.ac.ir

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Skin Diseases and Leishmaniasis Research Centre (SDLRC) at the University of Iran (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19248655

Publication citations

  1. Results

    Nilforoushzadeh MA, Jaffary F, Ansari N, Siadat AH, Nilforoushan Z, Firouz A, A comparative study between the efficacy of systemic meglumine antimoniate therapy with standard or low dose plus oral omeprazole in the treatment of cutaneous leishmaniasis., J Vector Borne Dis, 2008, 45, 4, 287-291.

Additional files

Editorial Notes