Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

This study has been completed.
Sponsor:
Collaborator:
RTI Health Solutions
Information provided by (Responsible Party):
Tioga Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01100684
First received: April 6, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.


Condition Intervention Phase
Diarrhea Predominant Irritable Bowel Syndrome
Drug: Asimadoline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

Resource links provided by NLM:


Further study details as provided by Tioga Pharmaceuticals:

Primary Outcome Measures:
  • 12 Week Abdominal Pain and Stool (APS) Frequency Responder [ Time Frame: Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Compare the two treatment groups with respect to IBS-related abdominal pain [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Compare the two treatment groups with respect to stool frequency [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Compare the two treatment groups with respect to stool urgency [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Compare the two treatment groups with respect to IBS symptoms [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Compare the two treatment groups with respect to stool consistency scores [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Using the Bristol Stool Form Scale

  • Incidence of adverse events as a measure of tolerability [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]
  • Abnormalities of laboratory tests as a measure of tolerability [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 611
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
0.5 mg asimadoline bid
Drug: Asimadoline
0.5 mg Asimadoline BID
Other Names:
  • EMD 61 753
  • EMR 63 320
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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.
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100684

  Show 142 Study Locations
Sponsors and Collaborators
Tioga Pharmaceuticals
RTI Health Solutions
Investigators
Study Chair: Allen Mangel, M.D.Ph.D. CMO
  More Information

Additional Information:
No publications provided

Responsible Party: Tioga Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01100684     History of Changes
Other Study ID Numbers: ASMP3001
Study First Received: April 6, 2010
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tioga Pharmaceuticals:
diarrhea predominant irritable bowel syndrome

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 10, 2014