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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02385058
• Date of registration: 05/03/2015
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag Ltd.
• Public title: 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
• Scientific 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
• Date of first enrolment: October 2005
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02385058
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Janssen-Cilag Ltd Clinical Trial
• Affiliation: Janssen-Cilag Ltd.

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amoebiasis

Helminthiasis

Intervention(s)

Drug: Placebo

Drug: Quinfamide

Drug: Mebendazole

Primary Outcome(s)

Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba) [Time Frame: Day 21]

Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba) [Time Frame: Day 43]

Secondary Outcome(s)

Percentage of Participants with Improved Quality of Life [Time Frame: Day 43]

Number of Participants with Adverse Events (AEs) and Serious AEs [Time Frame: Screening up to follow-up (Day 43)]

Percentage of Participants with Abdominal Symptoms Relieve [Time Frame: Day 43]

Secondary ID(s)

CR003685

JC/AMO/REC/0605

MEBENDAZOLGAI3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors