NCT00381394

A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.

Completed Phase 2 Last updated 18 September 2017

What this trial tests

Phase 2 trial testing sitamaquine in Leishmaniasis, Visceral in 61 participants. Completed in 14 September 2007.

Timeline

4 August 2006

Primary endpoint
14 September 2007

14 September 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	4 August 2006
Primary completion	14 September 2007
Estimated completion	14 September 2007
Sites	3 locations across India

Drugs / interventions tested

• sitamaquine — full drug profile →

Conditions studied

• Leishmaniasis, Visceral — all drugs for Leishmaniasis, Visceral →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 16 to 50, any sex, with Leishmaniasis, Visceral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated oral efficacy against Leishmania donovani. The purposes of this study are to characterise the pharmacokinetic profile of sitamaquine, administered orally, and to determine if the pharmacokinetic profile is affected by administration with food. The study is also designed to further characterise the safety and tolerability of sitamaquine compared with amphotericin B, particularly in reference to renal, hepatic and cardiac adverse events, prior to initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day treatment course. Previous studies have used 28 days dosing, but parasitological evidence from one study suggests that shorter courses may be effective.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetics of oral sitamaquine taken with or without food and safety and efficacy for treatment of visceral leishmaniais: a randomized study in Bihar, India.
   Sundar S, Sinha PK, Dixon SA, Buckley R, et al · · 2011 · cited 18× · PMID 21633025 · DOI 10.4269/ajtmh.2011.10-0409