Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00547469
Eligibility Criteria:
Inclusion Criteria:
* Female from 18 to 65 years of age, inclusive
* Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:
* Improvement with defecation
* Onset associated with a change in frequency of stool
* Onset associated with a change in form (appearance) of stool
* Negative serum and urine pregnancy tests
* Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization
Exclusion Criteria:
* Serious underlying diseases, including psychiatric disorders
* Current history of conditions affecting bowel transit
* Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
* Clinically significant abnormal examination findings or laboratory tests
* Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
* Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
* Presence of a medical condition which could interfere with the interpretation of study data
* Significant use of nicotine or caffeine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00547469
Study Brief:
Protocol Section:
NCT00547469