Irritable Bowel Syndrome With DiarrheaPhase 2NCT02757105
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study testing BEKINDA in people with Irritable Bowel Syndrome With Diarrhea, run by RedHill Biopharma Limited at 16 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- BEKINDA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 16 sitesUnited States
- Study dates
- 19 May 2016to 14 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age≥18 years (with a minimum of 35% males in the study)
- Patient meets FDA guidance and Rome III criteria for IBS-D:
- Recurrent abdominal pain or discomfort over ≥6 months, with frequency ≥3 days/month in the last 3 months associated with ≥2 of the following: i. Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in the form of stool b. Loose or watery stools (Bristol stool form scale 6 or 7) ≥2 days per week
- Average worst daily pain intensity ≥3.0 for each of the two baseline weeks
- Major laboratory parameters within the following limits (no worse than grade 1 abnormalities per NCI-CTCAE v4):
- Adequate hematologic function, as demonstrated by i. Hemoglobin ≥10 g/dL ii. Absolute neutrophil count (ANC) 1.5-10 x 10^9/L iii. Platelets ≥100 x 10^9/L b. Adequate liver and renal function as demonstrated by i. Aspartate transaminase (AST) and Alanine transaminase (ALT) each ≤ 3.0 x upper limit of normal (ULN) ii. Total bilirubin ≤1.5 x ULN iii. Creatinine ≤1.5 X ULN c. Euthyroid based on thyroid-stimulating hormone (TSH) and free T4 levels
Show all 10Show fewer
- Patients on thyroid hormone replacement must be on a stable dose for at least one month prior to study entry.
- C-reactive protein ≤2 x ULN for lab
- Patients of childbearing potential and male patients with partners of childbearing potential must utilize effective contraceptive measures Women of childbearing potential are women who have menstruated in the past 12 months, with the exception of women who have undergone surgical sterilization
- All patients must sign informed consent.
Who cannot join
- Evidence of other cause for bowel disease:
- Relevant abnormalities seen on colonoscopy if previously performed or if required per this protocol. These include but are not limited to Crohn's disease, ulcerative colitis, diverticulitis, ischemic colitis, microscopic colitis.
- History of and/or positive serologic test for celiac disease
- Known or suspected lactose intolerance.
- History of abdominal surgery other than appendectomy or cholecystectomy at any time
- Any elective major surgery (of any organ) planned for the period of the study, including follow-up
Show all 22Show fewer
- History of organic abnormalities of the GI tract including but not limited to intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aortoiliac disease)
- Current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas). With approval of the medical monitor patients with curatively treated neoplasm in complete remission <5 years may be entered in the study.
- Patients with a history of positive tests for ova or parasites or Clostridium difficile must be retested during the screening period and tests for the relevant agents must be negative
- Use of any 5-HT3 antagonist (5hydroxytryptamine receptor antagonists) within 4 weeks of the start of baseline data collection.
- Use of rifaximin within 4 months of the start of baseline data collection.
- Use of any other agent specific for IBS (such as alosetron or eluxadoline) or for symptomatic treatment of IBS (such as antispasmotics and antidiarrheals other than loperamide) within 2 weeks of the start of baseline data collection.
- Uses of any investigational agent for any indication within 4 weeks of the start of baseline data collection.
- Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT syndrome
- Patients who have Corrected QT interval (QTc) prolongation>450 msec noted on screening ECG, or who are taking medication known to cause QT prolongation
- Note: For current list of medications known to cause QT prolongation see:
- https://www.crediblemeds.org/healthcare-providers/drug-list/ There are several risk categories. Use the list showing those drugs known to cause torsade de pointes (TdP)
- Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists
- Patient has taken apomorphine within 24 hours of screening
- Pregnant or lactating
- Patients with other major illnesses, either physical or psychiatric, or social situations which may interfere with participation in the study or interpretation of results
- Patients with severe hepatic impairment, defined as Child-Pugh score ≥10 at baseline
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Bristol Hospital Dba Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010
Aztec Medical Research, LLC
Channelview, Texas, 77530
Clinsearch
Chattanooga, Tennessee, 37421
Prx Clinical
Garden Grove, California, 92840
Clinical Research of Homestead
Homestead, Florida, 33030
Clinical Research Associates, LLC
Huntsville, Alabama, 35801
E Squared Research, Inc.
Huntsville, Alabama, 35801
New Phase Research & Development
Knoxville, Tennessee, 37909
Endoscoopy Center of AR
Little Rock, Arkansas, 72212
Great Lakes Medical Research
Mentor, Ohio, 44060
Providence Clinical Research
North Hollywood, California, 91606
Arkansas Gastroenterology, P.A.
North Little Rock, Arkansas, 72117
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Shahram Jacobs MD, Inc.
Sherman Oaks, California, 91403
Advanced Rx Clinical Research Group, Inc.
Westminster, California, 92683
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily.
Read the detailed description
All patients will undergo baseline evaluation including full history and physical, with particular attention to gastrointestinal symptomatology and findings, a standard set of safety laboratory examinations (CBC and platelet count, biochemical profile, urinalysis, serum thyroid-stimulating hormone (TSH) and free T4, INR), and 12-lead ECG. In addition, the following studies will be performed to exclude other causes of gastrointestinal symptoms:
- Serum testing for C-reactive protein and gluten sensitivity
- Colonoscopy if required per protocol
- Patients with a history of positive tests for ova, parasites or Clostridium difficile must undergo repeat testing, which must be negative, during the screening period. Starting during the baseline observation phase, all patients will keep diaries of symptomatology and stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997).
Patients will keep diaries of stool frequency and consistency, symptoms, study medication compliance, and use of all medications, including rescue medications, throughout the study.
Serum electrolyte assays (bicarbonate, calcium, chloride, magnesium, potassium, and sodium) will be performed at week 3 on study. Safety laboratory examinations will be performed during and after the treatment period in accordance with the study procedures schedule below.
Patients will be questioned periodically regarding concomitant medication use and the occurrence of adverse events.
Patients must complete at least 12 days of all baseline diary entries within the 14 day screening period to be eligible to participate in the study. Patients completing fewer than 12 days of diary entries may, at the investigator's discretion, repeat the screening period diary. As long as the patent can complete and enter the study within 6 weeks, baseline laboratory studies need not be repeated. If repeating the 2 weeks' baseline diary will result in a period longer than 6 weeks from consent to start of treatment, the medical monitor must be consulted prior to randomization.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- BEKINDA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEKINDADrug
Also called RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | BEKINDA 12 mg (Ondansetron Bimodal Release Tablets), once daily for 8 weeks Receives: Drug: BEKINDA |
| Group B | Placebo comparator | Placebo, once daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Stool Consistency Response Rate Males - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Stool Consistency Response Rate Females - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Stool Consistency Response Rate: Sensitivity Analysis Without Imputation for Use of Rescue Medication - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP > Median - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP ≤ Median - mITT Population
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Secondary outcomes (2)
Summary and Analysis of Overall Worst Abdominal Pain Response Rate - mITT Population
A weekly pain responder was defined as a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score ≥30% compared with baseline and no increase in the number of days per week with Type 6 or 7 stool consistency. An overall pain responder was defined as a patient who was a weekly pain responder for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Summary and Analysis of Overall Study Response Rate - mITT Population
A patient was characterized as an overall weekly responder if the patient met both the stool consistency and pain response definitions for a given week. A patient was characterized as a composite study responder if the patient met the criteria for both weekly stool consistency and pain response for at least 50% of the planned weeks of treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start19 May 2016
- Primary completion16 Jun 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel Syndrome With 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757105
- Sponsor's protocol ID
- RHB-102-02
- Status last verified
- Jul 2018
- First submitted
- 27 Apr 2016
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT02757105
- Acronym / sponsor ID
- RHB-102-02
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 May 2016 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily.
Detailed description
All patients will undergo baseline evaluation including full history and physical, with particular attention to gastrointestinal symptomatology and findings, a standard set of safety laboratory examinations (CBC and platelet count, biochemical profile, urinalysis, serum thyroid-stimulating hormone (TSH) and free T4, INR), and 12-lead ECG. In addition, the following studies will be performed to exclude other causes of gastrointestinal symptoms:
- Serum testing for C-reactive protein and gluten sensitivity
- Colonoscopy if required per protocol
- Patients with a history of positive tests for ova, parasites or Clostridium difficile must undergo repeat testing, which must be negative, during the screening period. Starting during the baseline observation phase, all patients will keep diaries of symptomatology and stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997).
Patients will keep diaries of stool frequency and consistency, symptoms, study medication compliance, and use of all medications, including rescue medications, throughout the study.
Serum electrolyte assays (bicarbonate, calcium, chloride, magnesium, potassium, and sodium) will be performed at week 3 on study. Safety laboratory examinations will be performed during and after the treatment period in accordance with the study procedures schedule below.
Patients will be questioned periodically regarding concomitant medication use and the occurrence of adverse events.
Patients must complete at least 12 days of all baseline diary entries within the 14 day screening period to be eligible to participate in the study. Patients completing fewer than 12 days of diary entries may, at the investigator's discretion, repeat the screening period diary. As long as the patent can complete and enter the study within 6 weeks, baseline laboratory studies need not be repeated. If repeating the 2 weeks' baseline diary will result in a period longer than 6 weeks from consent to start of treatment, the medical monitor must be consulted prior to randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BEKINDABEKINDA 12 mg (Ondansetron Bimodal Release Tablets), once daily for 8 weeks |
| Group B | Placebo comparator | Drug: PlaceboPlacebo, once daily for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients age≥18 years (with a minimum of 35% males in the study)
- Patient meets FDA guidance and Rome III criteria for IBS-D:
- Average worst daily pain intensity ≥3.0 for each of the two baseline weeks
- Major laboratory parameters within the following limits (no worse than grade 1 abnormalities per NCI-CTCAE v4):
- Patients on thyroid hormone replacement must be on a stable dose for at least one month prior to study entry.
Key exclusion criteria (22 listed)
- Evidence of other cause for bowel disease:
- History of abdominal surgery other than appendectomy or cholecystectomy at any time
- Any elective major surgery (of any organ) planned for the period of the study, including follow-up
- History of organic abnormalities of the GI tract including but not limited to intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aortoiliac disease)
- Current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas). With approval of the medical monitor patients with curatively treated neoplasm in complete remission <5 years may be entered in the study.
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 |
|---|---|---|
| BEKINDAAlso: RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg | Drug | Group A |
| Placebo | Drug | Group B |
Primary outcome
Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Summary and Analysis of Overall Stool Consistency Response Rate Males - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Summary and Analysis of Overall Stool Consistency Response Rate Females - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Summary and Analysis of Overall Stool Consistency Response Rate: Sensitivity Analysis Without Imputation for Use of Rescue Medication - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP > Median - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP ≤ Median - mITT Population
Time frame: 8 weeks
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
2 secondary outcomes
Summary and Analysis of Overall Worst Abdominal Pain Response Rate - mITT Population
Time frame: 8 weeks
Summary and Analysis of Overall Study Response Rate - mITT Population
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEKINDA in people with Irritable Bowel Syndrome With Diarrhea, run by RedHill Biopharma Limited at 16 sites in United States.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018.