Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Weekly Tafenoquine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02491606
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
SmithKline Beecham
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Brief Summary:
This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.

Condition or disease Intervention/treatment Phase
Malaria Drug: Tafenoquine Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
Study Start Date : May 1997
Actual Primary Completion Date : September 1997
Actual Study Completion Date : September 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Load only
Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
Drug: Tafenoquine
Tafenoquine 200mg and 400 mg

Experimental: Low weekly dose
Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
Drug: Tafenoquine
Tafenoquine 200mg and 400 mg

Experimental: High weekly dose
Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.
Drug: Tafenoquine
Tafenoquine 200mg and 400 mg

Experimental: Placebo
Loading with placebo for 3 days followed by placebo once weekly.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Prophylactic outcome. [ Time Frame: 13 Weeks ]

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.



Secondary Outcome Measures :
  1. Prophylactic outcome after 7 weeks [ Time Frame: 7 Weeks ]

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.


  2. Prophylactic outcome after 10 weeks [ Time Frame: 10 Weeks ]

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy subjects (male or female)
  2. Age of 18-55 years
  3. Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion Criteria:

  1. Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
  2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
  3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
  4. Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
  5. Known hypersensitivity to any study drug.
  6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
  7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491606


Sponsors and Collaborators
U.S. Army Medical Research and Development Command
SmithKline Beecham
Investigators
Layout table for investigator information
Principal Investigator: A.J Oloo Kenya Medical Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02491606    
Other Study ID Numbers: A-7540
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents