Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
Double-Blind, Placebo-Controlled, Randomized, Prospective, Two-Stage, Two-Arm Study to Evaluate the Efficaciousness and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
3 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2005
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedApril 14, 2015
April 1, 2015
3 months
March 5, 2015
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
Day 21
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
Day 43
Secondary Outcomes (3)
Percentage of Participants with Abdominal Symptoms Relieve
Day 43
Percentage of Participants with Improved Quality of Life
Day 43
Number of Participants with Adverse Events (AEs) and Serious AEs
Screening up to follow-up (Day 43)
Study Arms (2)
Mebendazole + Quinfamide
EXPERIMENTALParticipants will receive mebendazole 600 milligram (mg) and quinfamide 200 mg tablets orally once starting on Day 1 and 21 in both Phase 1 and 2.
Mebendazole + Quinfamide + Placebo
EXPERIMENTALParticipants will receive mebendazole 600 mg and quinfamide 200 mg tablets orally once starting on Day 1 in Phase 1 and placebo tablets orally once starting on Day 21 in Phase 2.
Interventions
Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.
Quinfamide 200 mg tablet orally once starting on Day 1 and 21.
Eligibility Criteria
You may qualify if:
- Minors whose parents or tutor grant his/her informed consent in writing to participate in the study. Adult participants that give their informed consent in writing to participate
- Participants having a copro-parasitoscopy test (scatology) (at least 1 with a series of 3) qualitative and quantitative and/or search of live amoeba, that comes out positive for one or more of the following parasites: Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichuria, Taenia solium, Necator americanus, Ancylostoma duodenale and Trophozoites of Entamoeba histolytica
- With at least two or more of the following symptoms: Anorexia, Nausea, Vomit, Abdominal pain, Diarrhea, Constipation, Evacuations with mucus, Evacuations with blood, Gas discharge, Weight loss and Bruxism
You may not qualify if:
- Participants with any known allergy to any of the drugs used in the investigation
- Female Participant in reproductive age not using an adequate contraceptive method
- Pregnant or lactating Participant
- Participant with any life-threatening condition (cancer, AIDS, etc.)
- Participant known to be a carrier of some illness that alters the metabolism or drug excretion (hepatic or renal illness) interfering with the absorption (malabsorption) or interferes with the evaluation of the Participant during the study
- Participants with diagnosis of extra-intestinal amoebiasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Ltd Clinical Trial
Janssen-Cilag Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 11, 2015
Study Start
October 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
April 14, 2015
Record last verified: 2015-04