Status:
COMPLETED
Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
IBS, Diarrhea Predominant
IBS, Constipation Predominant
Eligibility:
All Genders
18-75 years
Brief Summary
Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, ...
Eligibility Criteria
Inclusion
- The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
- The subject has been diagnosed with either IBS-C, IBS-D, IBS-M, or has no history of gastrointestinal symptoms (control group).
- The subject has at least 3 pain episodes a week and does not have constant, unremitting abdominal pain.
- The subject is at least 18 years of age and less than 75 years of age at the time of the screening visit.
- The subject is fluent in English.
- The subject is an ambulatory outpatient. Ambulatory is defined as not depending exclusively on a wheelchair for mobility. Nursing home subjects may be enrolled provided they are ambulatory. Subjects with spinal cord injuries resulting in paraplegia may not be enrolled.
Exclusion
- The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but are not limited to) the following:
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis),
- GI surgery (with the exceptions of appendectomy; cholecystectomy; benign polypectomy; fundoplication without gas bloat syndrome, 6 months post-surgery; herniorrhaphy without bowel resection, 1 month post-surgery; hemorrhoidectomy, at least 2 months post-surgery; and hiatal hernia repair),
- GI malignancy, GI obstruction
- In the opinion of the investigator the 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).
- The subject has been diagnosed with a major psychiatric disorder within the past 2 years that required hospitalization and/or involved an attempted suicide (e.g., major depression or psychoses). Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
- The subject has a history of alcohol or substance abuse within the past 2 years.
- The subject has any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous 5 years.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00619125
Start Date
April 1 2008
End Date
April 1 2009
Last Update
June 20 2017
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