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| ID | Type | Description | Link |
|---|---|---|---|
| JC/AMO/REC/0605 | Other Identifier | Janssen-Cilag Ltd | |
| MEBENDAZOLGAI3001 | Other Identifier | Janssen-Cilag Ltd |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mebendazole + Quinfamide | Experimental | Participants 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 | Experimental | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mebendazole | Drug | Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Abdominal Symptoms Relieve | Evaluation of abdominal symptoms relief will be carried by the questionnaires, each one of the symptoms presence will be evaluated determining its presence or absence, intensity, and changes throughout the treatment period. | Day 43 |
| Percentage of Participants with Improved Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mexico City | Mexico |
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| Quinfamide | Drug | Quinfamide 200 mg tablet orally once starting on Day 1 and 21. |
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| Placebo | Drug | Placebo tablet orally once starting on Day 21. |
|
Evaluation of improved quality of life will be carried by the questionnaires, the results will be evaluated according to the symptomatic satisfaction scales, scale ranges from Excellent to Terrible (Excellent = very satisfied, Good= satisfied, Poor= more or less satisfied, Bad= unsatisfied and Terrible= very unsatisfied), which should show that there was an improvement in the sensation of wellbeing of the participant compared with the symptoms provoked by the presence of the intestinal parasitosis. |
| Day 43 |
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Screening up to follow-up (Day 43) |
| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| D000562 | Amebiasis |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D011528 | Protozoan Infections |
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| ID | Term |
|---|---|
| D008463 | Mebendazole |
| C026546 | quinfamide |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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