A Phase 2 interventional study of iOWH032 in Secretory Diarrhea, sponsored by PATH. Withdrawn at 1 site in Bangladesh. Open to participants aged 5 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-09-26.
Sponsored by PATH · Phase 2, Interventional, and Treatment
The primary hypothesis is that administration of iOWH032 to adult and pediatric males and females with acute cholera due to V. cholerae O1 reduces stool output in the first 24 hours significantly more than does the current standard of care.
This is a Phase 2, randomized, double-blind, placebo-controlled study of iOWH032 in adult patients (Part A) and then pediatric patients (Part B) with acute watery diarrhea of less than 24 hours' duration due to cholera. All subjects will be treated with standard of care (IV rehydration fluids, ORS, and azithromycin less than/equal to1 g po) in addition to study drug (iOWH032 active drug or placebo). Patients will be admitted, undergo a 4- to 6-hour screening/observation period, be randomized in the study and treated with study drug (active or placebo) for up to 3 days (ie, up to 9 doses), with a follow-up visit on Day 7.
In Part A, approximately 170 adult patients with severe dehydrating diarrhea due to cholera will be enrolled and randomized 1:1 to receive iOWH032 500 mg or placebo TID for up to 3 days. Following completion of Part A, the data and safety monitoring board (DSMB) will review the unblinded data to assess safety and efficacy and conduct a futility analysis prior to proceeding to Part B.
Following the DSMB recommendation of dose and dosing schedule for pediatric patients, Part B will be initiated. Approximately 156 pediatric patients with severe dehydrating diarrhea due to cholera will be enrolled and randomized 1:1 to receive iOWH032 or placebo at the recommended dose and dosing regimen.
The primary efficacy population for Parts A and B will consist of patients who tolerate the first 3 doses of study drug (0, 8, and 16 hours post-randomization) without vomiting and whose diagnosis is subsequently confirmed by a positive culture for V. cholerae O1.
The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) Ethics Committee and Western Institutional Review Board (WIRB) will be informed of any serious adverse event (SAE). Occurrence of 2 or more drug-related SAEs within a group of 10 patients (20% of cumulative completed patients in the treatment group) in Part A or Part B will result in unblinding of those patients and review by the DSMB. The study can be halted, discontinued, or amended according to the recommendations of the icddr,b DSMB.
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Approximately 170 adult (male and female) patients must be enrolled to ensure that 96 patients (48 active and 48 placebo) are evaluable in Part A. In Part B, approximately 156 pediatric patients will be enrolled to ensure that 120 pediatric patients (60 active and 60 placebo) are evaluable for the analysis of 24 hour stool output, the primary outcome measure.
PART A - ADULTS
***Inclusion Criteria***
A patient will be considered eligible for participation in the study if the following inclusion criteria are satisfied on admission (Day 1) to the Dhaka Hospital of icddr,b:
***Exclusion Criteria***
A patient with any of the following criteria at screening for study enrollment will not qualify for the study:
PART B - PEDIATRIC
***Inclusion Criteria***
A patient will be considered eligible for participation in the study if the following inclusion criteria are satisfied on admission (Day 1) to the Clinical Research Ward (CRW) of Dhaka Hospital:
***Exclusion Criteria***
A patient with any of the following criteria at screening for study enrollment will not qualify for the study:
In Part A, approximately 170 adult patients with severe dehydrating diarrhea due to cholera will be enrolled and randomized 1:1 to receive iOWH032 500 mg or placebo TID for up to 3 days
Drug: iOWH032
Following completion of Part A, the data and safety monitoring board (DSMB) will review the unblinded data to assess safety and efficacy and conduct a futility analysis prior to proceeding to Part B. Following the DSMB recommendation of dose and dosing schedule for pediatric patients, Part B will be initiated. Approximately 156 pediatric patients with severe dehydrating diarrhea due to cholera will be enrolled and randomized 1:1 to receive iOWH032 or placebo at the recommended dose and dosing regimen.
Drug: iOWH032
Output (mL/kg of body weight) of unformed stools (composite)
The primary objectives of the study are as follows: * To evaluate the efficacy of iOWH032 in adults with cholera, as measured by unformed stool output in the first 24 hours after administration (Part A) * To determine an effective dose and dosing regimen of iOWH032 in children with cholera (Part A) * To evaluate the efficacy of iOWH032 at this recommended dose and dosing regimen in children with cholera (Part B)
Time frame: First 24-hour period following randomization
Total stool output (mL/kg body weight) (composite)
* Total stool output (mL/kg body weight) from randomization until the resolution of diarrhea, or until 3 days (72 hours post-dose) after administration of the first dose of study drug, whichever is sooner * Time to resolution of diarrhea * Incidence of diarrhea resolution within 48 hours and within 72 hours from the time of administration of the first dose of study drug * Intake of ORS solution and plain water in mL/kg from time of randomization through the last unformed stool or until 3 days (72 hours) after administration of the first dose of study drug, whichever is sooner * Requirement for unscheduled IV rehydration therapy (mL/kg) after randomization * Sodium, potassium, chloride, cAMP, parent drug, and metabolite concentrations, all in the stool * Sensitivity, specificity, positive and negative predictive values, and accuracy of stool DF and RDT in the diagnosis of cholera, and the impact of antibiotic therapy on DF and RDT
Time frame: From randomization until the resolution of diarrhea, or until 3 days (72 hours post-dose) after administration of the first dose of study drug, whichever is sooner
Safety
The safety and tolerability endpoints for this study are AEs, clinical laboratory values, physical examination results, vital signs, and ECG findings. All patients in Part A and B of the study who receive study drug will be included in the safety analysis. Acceptability of the iOWH032 dispersible tablet or suspension formulation will be evaluated in Part B of the study (pediatric patients).
Time frame: Duration of Study
This study is withdrawn, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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