Clinical trial NCT02385058: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helminthiasis
Amoebiasis
Keywords: Helminthiasis
Amoebiasis
Mebendazole
Quinfamide
Mexican population
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (study medication assigned to participants by chance), prospective (study following patients forward in time) study. The total study duration for each participant will be approximately 48 days. The study will consist of 3 parts: Screening Phase (5 days) and double-blind treatment Phase (from Day 1 to 21, consists of Phase-1 and Phase-2) and follow-up Phase (from Day 21 to 43). Participants will receive mebendazole (600 milligram \[mg\]) and quinfamide (200 mg) tablets orally once starting on Day 1 and mebendazole 600 mg and quinfamide (200 mg) or placebo tablets orally once starting on Day 21. Efficacy will be primarily evaluated by percentage of participants with eradication of helminthic and/or protozoa. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 that have taken any antiparasitic drug 14 days previous to his/her inclusion in this clinical investigation protocol
* Participants with diagnosis of extra-intestinal amoebiasis

Primary outcomes:
measure: Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
timeFrame: Day 21
measure: Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
timeFrame: Day 43
Secondary outcomes:
measure: Percentage of Participants with Abdominal Symptoms Relieve
timeFrame: Day 43
measure: Percentage of Participants with Improved Quality of Life
timeFrame: Day 43
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (Day 43)
Other outcomes:
Locations:
city: Mex
country: Mexico
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References: