Secretory DiarrheaPhase 2POCNCT02111304
Efficacy of iOWH032 in Dehydrating Cholera
A Phase 2 study testing iOWH032 in people with Secretory Diarrhea, run by PATH at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Secretory Diarrhea
- What is being tested?
- iOWH032
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBangladesh
- Study dates
- Jun 2014to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- Adults aged 18 years to 55 years
- Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces
- Clinical signs and symptoms of severe dehydration (>10% loss of body weight based on rehydration weight)
- Stool RDT and/or stool DF microscopy demonstrating presence of V. cholerae
- Must have a purging rate greater than/equal to 20 mL/kg (5 mL/kg/h) during the initial 4- to 6-hour screening/observation period, and signs of clinical dehydration must be corrected
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- Written informed consent for participation in the study (see Section 6.1.2 for details of the consent process)
- Negative urine pregnancy test for all female patients
- Nonpregnant and nonlactating females of childbearing potential agree to either abstain from sex or use double barrier contraception (2 contraceptive methods at a time) during the study and until 1 month after the last dose of study drug
- 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:
- Pediatric population aged ≥ 5 years to < 18 years of age
- Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces
- Clinical signs and symptoms of severe dehydration (>10% loss of body weight based on rehydration weight)
- Stool RDT and/or stool DF microscopy demonstrating presence of V. cholerae
- Must have a purging rate ≥5 mL/kg/h average during the initial 4- to 6-hour screening/observation period and signs of clinical dehydration must be corrected
- Parental consent for all pediatric patients participating in the study and written informed assent for children aged 11-17 years (see Section 6.1.2 for details of the consent process)
- Negative urine pregnancy test for female postmenarchal patients
- Nonpregnant and nonlactating females of childbearing potential agree to either abstain from sex or use double-barrier contraception (2 contraceptive methods at a time) during the study and until 1 month after the last dose of study drug
Who cannot join
- A patient with any of the following criteria at screening for study enrollment will not qualify for the study:
- Received antidiarrheal medication (eg, loperamide, diphenoxylate) within 7 days before screening
- Abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate
- Use of drugs metabolized predominantly via CYP2C9 within 7 days before screening (see Section 5.7)
- Concomitant infection requiring antimicrobial therapy other than the study drug that may interfere with the evaluation of either the efficacy or safety of the study drug
- Patients unwilling or unable to take part in this study or refusing to sign informed consent (patients who participate on the basis of proxy consent will be re-consented at the end of the screening/observation period; those refusing consent at that time will be excluded from further study participation)
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- Patients previously enrolled in this or any other investigational study within the past 30 days
- PART B - PEDIATRIC
- A patient with any of the following criteria at screening for study enrollment will not qualify for the study:
- Received antidiarrheal medication (eg, loperamide, diphenoxylate) within 7 days before screening
- Abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate
- Use of drugs metabolized predominantly via CYP2C9 (see Section 5.7) within 7 days before screening
- Concomitant infection requiring antimicrobial therapy other than the study drug that may interfere with evaluation of either the efficacy or safety of the study drug
- Children or parents/guardians unwilling or unable to take part in this study or refusing to sign informed assent/consent; applicable patients who participate on the basis of proxy assent/consent will be re-assented at the end of the screening/observation period; those refusing assent/consent at that time will be excluded from further study participation
- Patients previously enrolled in this or any other investigational study with the past 30 days
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Trial to Evaluate the Efficacy, Safety, and Tolerability of iOWH032 in the Treatment of Acute Dehydrating Diarrhea in Adult and Pediatric Patients With Cholera
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.
Read the detailed description
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.
- Conditions
- Secretory Diarrhea
- Being tested
- iOWH032
- Keywords
- cholera, diarrhea, secretory diarrhea, ORS, V. cholerae O1, iOWH032, children, pharmacokinetic, Bangladesh
- Medical subject headings
- Cholera, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iOWH032Drug
| Study group | Role | What they receive |
|---|---|---|
| Part A (Adults) | Active comparator | 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 Receives: Drug: iOWH032 |
| Part B (Pediatric) | Active comparator | 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. Receives: Drug: iOWH032 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: First 24-hour period following randomization
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Trial was never initiated due to PATH executive decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Secretory DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Wasif A Khan, MBBS/MHS, Principal investigator, International Centre for Diarrhoeal Disease Research, BangladeshKATM Ehsanul Huq, MBBS/DTM, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111304
- Sponsor's protocol ID
- POC Study (DDP CFT PO 202)
- Acronym
- POC
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bardhan PK, Khan WA, Ahmed S, Salam MA, Saha D, Golman D, et al. Evaluation of safety and efficacy of a novel anti-secretory anti-diarrheal agent Crofelemer (NP-303), in combination with a single oral dose of azithromycin for the treatment of acute dehydrating diarrhea caused by Vibrio cholera cholera and other Bacterial Infections: 43rd US-Japan Cooperative Medical Science Program, Kyoto, Japan, November 21, 2008.
Boschi-Pinto C, Lanata CF, Black RE. The global burden of childhood diarrhea. Matern Child Health. 2009;3: 225-243.
Cystic Fibrosis Mutation Database, 2009 [online] Available at: http://www.genet.sickkids.on.ca/cftr/app
Khan WA, Saha D, Rahman A, Salam MA, Bogaerts J, Bennish ML. Comparison of single-dose azithromycin and 12-dose, 3-day erythromycin for childhood cholera: a randomised, double-blind trial. Lancet. 2002 Nov 30;360(9347):1722-7. doi: 10.1016/S0140-6736(02)11680-1.
PubMed 12480424Muanprasat C, Sonawane ND, Salinas D, Taddei A, Galietta LJ, Verkman AS. Discovery of glycine hydrazide pore-occluding CFTR inhibitors: mechanism, structure-activity analysis, and in vivo efficacy. J Gen Physiol. 2004 Aug;124(2):125-37. doi: 10.1085/jgp.200409059.
PubMed 15277574Raghupathy P, Ramakrishna BS, Oommen SP, Ahmed MS, Priyaa G, Dziura J, Young GP, Binder HJ. Amylase-resistant starch as adjunct to oral rehydration therapy in children with diarrhea. J Pediatr Gastroenterol Nutr. 2006 Apr;42(4):362-8. doi: 10.1097/01.mpg.0000214163.83316.41.
PubMed 16641573Ram PK, Choi M, Blum LS, Wamae AW, Mintz ED, Bartlett AV. Declines in case management of diarrhoea among children less than five years old. Bull World Health Organ. 2008 Mar;86(3):E-F. doi: 10.2471/blt.07.041384. No abstract available.
PubMed 18368194Saha D, Karim MM, Khan WA, Ahmed S, Salam MA, Bennish ML. Single-dose azithromycin for the treatment of cholera in adults. N Engl J Med. 2006 Jun 8;354(23):2452-62. doi: 10.1056/NEJMoa054493.
PubMed 16760445StataCorp. POWERCAL: Stata module to perform general power and sample size calculations. http://ideas.repec.org/c/boc/bocode/s422401.html. 2013. Stata Statistical Software: Release 13. StataCorp LP, College Station, TX.
United Nations Children's Fund (UNICEF) and World Health Organization (WHO). Diarrhoea: Why children are still dying and what can be done. 2009. New York and Geneva.
Verkman AS, Galietta LJ. Chloride channels as drug targets. Nat Rev Drug Discov. 2009 Feb;8(2):153-71. doi: 10.1038/nrd2780. Epub 2008 Jan 19.
PubMed 19153558Victora CG, Bryce J, Fontaine O, Monasch R. Reducing deaths from diarrhoea through oral rehydration therapy. Bull World Health Organ. 2000;78(10):1246-55.
PubMed 11100619World Health Organization. The rational use of drugs in the management of acute diarrhoea in children. WHO, Geneva, 1990.
Zhou Z, Wang X, Liu HY, Zou X, Li M, Hwang TC. The two ATP binding sites of cystic fibrosis transmembrane conductance regulator (CFTR) play distinct roles in gating kinetics and energetics. J Gen Physiol. 2006 Oct;128(4):413-22. doi: 10.1085/jgp.200609622. Epub 2006 Sep 11.
PubMed 16966475
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Trial to Evaluate the Efficacy, Safety, and Tolerability of iOWH032 in the Treatment of Acute Dehydrating Diarrhea in Adult and Pediatric Patients With Cholera
- ClinicalTrials.gov ID
- NCT02111304
- Acronym / sponsor ID
- POC / POC Study (DDP CFT PO 202)
- Conditions
- Secretory Diarrhea
- Keywords
- cholera, diarrhea, secretory diarrhea, ORS, V. cholerae O1, iOWH032, children, pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was never initiated due to PATH executive decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (Adults) | Active comparator | Drug: iOWH032In 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 |
| Part B (Pediatric) | Active comparator | Drug: iOWH032Following 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. |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 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:
- Adults aged 18 years to 55 years
- Duration of illness: History of acute watery diarrhea of less than 24 hours' duration without fever or visible blood in feces
- Clinical signs and symptoms of severe dehydration (>10% loss of body weight based on rehydration weight)
- Stool RDT and/or stool DF microscopy demonstrating presence of V. cholerae
Key exclusion criteria (15 listed)
- A patient with any of the following criteria at screening for study enrollment will not qualify for the study:
- Received antidiarrheal medication (eg, loperamide, diphenoxylate) within 7 days before screening
- Abnormal ECG findings, with the exception of sinus tachycardia, premature atrial contractions, or ECG intervals within normal limits for sinus rate
- Use of drugs metabolized predominantly via CYP2C9 within 7 days before screening (see Section 5.7)
- Concomitant infection requiring antimicrobial therapy other than the study drug that may interfere with the evaluation of either the efficacy or safety of the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iOWH032 | Drug | Part A (Adults), Part B (Pediatric) |
Primary outcome
Output (mL/kg of body weight) of unformed stools (composite)
Time frame: First 24-hour period following randomization
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)
1 secondary outcome
Total stool output (mL/kg body weight) (composite)
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- BackgroundBardhan PK, Khan WA, Ahmed S, Salam MA, Saha D, Golman D, et al. Evaluation of safety and efficacy of a novel anti-secretory anti-diarrheal agent Crofelemer (NP-303), in combination with a single oral dose of azithromycin for the treatment of acute dehydrating diarrhea caused by Vibrio cholera cholera and other Bacterial Infections: 43rd US-Japan Cooperative Medical Science Program, Kyoto, Japan, November 21, 2008.
- BackgroundBoschi-Pinto C, Lanata CF, Black RE. The global burden of childhood diarrhea. Matern Child Health. 2009;3: 225-243.
- BackgroundCystic Fibrosis Mutation Database, 2009 [online] Available at: http://www.genet.sickkids.on.ca/cftr/app
- Background: PubMed 12480424Khan WA, Saha D, Rahman A, Salam MA, Bogaerts J, Bennish ML. Comparison of single-dose azithromycin and 12-dose, 3-day erythromycin for childhood cholera: a randomised, double-blind trial. Lancet. 2002 Nov 30;360(9347):1722-7. doi: 10.1016/S0140-6736(02)11680-1.
- Background: PubMed 15277574Muanprasat C, Sonawane ND, Salinas D, Taddei A, Galietta LJ, Verkman AS. Discovery of glycine hydrazide pore-occluding CFTR inhibitors: mechanism, structure-activity analysis, and in vivo efficacy. J Gen Physiol. 2004 Aug;124(2):125-37. doi: 10.1085/jgp.200409059.
- Background: PubMed 16641573Raghupathy P, Ramakrishna BS, Oommen SP, Ahmed MS, Priyaa G, Dziura J, Young GP, Binder HJ. Amylase-resistant starch as adjunct to oral rehydration therapy in children with diarrhea. J Pediatr Gastroenterol Nutr. 2006 Apr;42(4):362-8. doi: 10.1097/01.mpg.0000214163.83316.41.
- Background: PubMed 18368194Ram PK, Choi M, Blum LS, Wamae AW, Mintz ED, Bartlett AV. Declines in case management of diarrhoea among children less than five years old. Bull World Health Organ. 2008 Mar;86(3):E-F. doi: 10.2471/blt.07.041384. No abstract available.
- Background: PubMed 16760445Saha D, Karim MM, Khan WA, Ahmed S, Salam MA, Bennish ML. Single-dose azithromycin for the treatment of cholera in adults. N Engl J Med. 2006 Jun 8;354(23):2452-62. doi: 10.1056/NEJMoa054493.
- BackgroundStataCorp. POWERCAL: Stata module to perform general power and sample size calculations. http://ideas.repec.org/c/boc/bocode/s422401.html. 2013. Stata Statistical Software: Release 13. StataCorp LP, College Station, TX.
- BackgroundUnited Nations Children's Fund (UNICEF) and World Health Organization (WHO). Diarrhoea: Why children are still dying and what can be done. 2009. New York and Geneva.
- Background: PubMed 19153558Verkman AS, Galietta LJ. Chloride channels as drug targets. Nat Rev Drug Discov. 2009 Feb;8(2):153-71. doi: 10.1038/nrd2780. Epub 2008 Jan 19.
- Background: PubMed 11100619Victora CG, Bryce J, Fontaine O, Monasch R. Reducing deaths from diarrhoea through oral rehydration therapy. Bull World Health Organ. 2000;78(10):1246-55.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasif A Khan, MBBS/MHS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
KATM Ehsanul Huq, MBBS/DTM principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iOWH032 in people with Secretory Diarrhea, run by PATH at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Output (mL/kg of body weight) of unformed stools (composite) (time frame: First 24-hour period following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111304, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.