Diarrhea Predominant Irritable Bowel Syndrome
Conditions
Keywords
diarrhea predominant irritable bowel syndrome
Brief summary
The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.
Detailed description
The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters: * Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score * Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an overall study responder, defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.
Interventions
DRUGAsimadoline
0.5 mg Asimadoline BID
DRUGPlacebo
Placebo
Sponsors
RTI Health Solutions
Tioga Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Signs and dates a written informed consent form. 2. Male and female subjects aged 18-79 who are fluent in English 3. All subjects must use protocol specified contraceptive measures 4. The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms: Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool 5. The subject has been diagnosed with diarrhea-predominant IBS 6. Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm.
Exclusion criteria
1. The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. 2. Subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition). 3. The subject has a family history of prolonged QT syndrome. 4. The subject has been diagnosed with a major psychiatric disorder. 5. The subject has a history of alcohol or substance abuse within the past 2 years. 6. The subject has a history or current evidence of laxative abuse 7. The subject has a positive stool sample for ova or parasite. 8. The subject has used an investigational drug or participated in an investigational study within 30 days of screening. 9. The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit. 10. The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit. 11. The subject is a pregnant woman or a woman who is breast feeding. 12. The subject is unable or unwilling to follow directions or use the electronic diary system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Week Abdominal Pain and Stool (APS) Frequency Responder | Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder | A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the two treatment groups with respect to stool frequency | Up to 12 weeks | — |
| Compare the two treatment groups with respect to stool urgency | Up to 12 weeks | — |
| Compare the two treatment groups with respect to IBS symptoms | up to 12 weeks | — |
| Compare the two treatment groups with respect to IBS-related abdominal pain | Up to 12 weeks | — |
| Incidence of adverse events as a measure of tolerability | Up to 16 weeks | — |
| Abnormalities of laboratory tests as a measure of tolerability | Up to 16 weeks | — |
| Compare the two treatment groups with respect to stool consistency scores | Up to 12 weeks | Using the Bristol Stool Form Scale |
Countries
United States
Outcome results
None listed