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NCT00545935
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
Phase 2 trial testing Methylenblue-Amodiaquine (MB-AQ) in Malaria in 186 participants. Completed in 1 October 2007.
Quick facts
| Lead sponsor | Heidelberg University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 186 |
| Start date | 1 July 2007 |
| Estimated completion | 1 October 2007 |
| Sites | 1 location across Burkina Faso |
Drugs / interventions tested
- Methylenblue-Amodiaquine (MB-AQ) — full drug profile →
- Methylenblue-Artesunate (MB-AS) — full drug profile →
- Artesunate-Amodiaquine (AS-AQ) — full drug profile →
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
Heidelberg University
Who can join
Adults 6 Months to 59 Months, any sex, with Malaria.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Time frame: 28 days
Sponsor's own description
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00545935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Heidelberg University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00545935 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Heidelberg University
- Last refreshed: 2 February 2009
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/NCT00545935.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing