NCT01047436 is a Phase 2 clinical trial of Quinine in Falciparum Malaria, sponsored by Proto Pharma Ltd.

Who is sponsoring NCT01047436?

NCT01047436 is sponsored by Proto Pharma Ltd.

What drugs are being tested in NCT01047436?

Interventions in NCT01047436: Quinine, Artemether.

What condition does NCT01047436 study?

NCT01047436 studies Falciparum Malaria.

Is NCT01047436 still recruiting?

NCT01047436 is currently completed. Last updated 26 January 2011.

Are results published for NCT01047436?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-01-26 · How we verify

NCT01047436

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label Randomised Comparative Trial to Establish the Efficacy of 3 mg/kg ArTiMist™ When Compared to Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications

Completed Phase 2 Results posted Last updated 26 January 2011

What this trial tests

Phase 2 trial testing Quinine in Falciparum Malaria in 31 participants. Completed in 1 January 2010.

Timeline

1 December 2009

Primary endpoint
1 January 2010

1 January 2010

Quick facts

Lead sponsor	Proto Pharma Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	1 December 2009
Primary completion	1 January 2010
Estimated completion	1 January 2010

Drugs / interventions tested

Quinine (QUININE) — full drug profile →
Artemether (ARTEMETHER) — full drug profile →

Conditions studied

Falciparum Malaria — all drugs for Falciparum Malaria →

Sponsor

Proto Pharma Ltd — full company profile →

Who can join

Eligibility, any sex, with Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
Time frame: 24 hours after first dose
Time for Parasite Count to Fall by 90% PCT(90)
Time frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 90% from baseline
Time for Parasite Count to Fall by 50% PCT(50)
Time frame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 50% from baseline

Sponsor's own description

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The global pipeline of new medicines for the control and elimination of malaria.
Anthony MP, Burrows JN, Duparc S, Moehrle JJ, et al · · 2012 · cited 100× · PMID 22958514 · DOI 10.1186/1475-2875-11-316
Efficacy of a novel sublingual spray formulation of artemether in African children with Plasmodium falciparum malaria.
Bendel D, Rulisa S, Ansah P, Sirima S. · · 2015 · cited 2× · PMID 26303805 · DOI 10.1128/aac.00243-15

Verify or expand the search:

Other trials of Quinine

Trials testing the same drug.

NCT05682339 — Effects of Intragastric Quinine, Alone or Combined With L-isoleucine, on Postprandial Glycaemic Control · NA · completed
NCT05720390 — Effects of Intragastric Quinine, Alone or Combined With L-leucine, on Postprandial Glycaemic Control · NA · completed

Other recruiting trials for Falciparum Malaria

Currently open trials in the same condition.

NCT05911828 — A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combina · Phase 1 · recruiting
NCT06529237 — Malaria Molecular Surveillance in Mozambique (Phase 2) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01047436 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Proto Pharma Ltd
Last refreshed: 26 January 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01047436.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing