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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT00277550
Eligibility Criteria:
Inclusion Criteria:
* Females aged 18 to 64 years of age
* Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:
1. Less than 3 bowel movements per week
2. Hard or lumpy stools
3. Straining during bowel movements
4. Feeling of incomplete evacuation
* Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating
Exclusion Criteria:
* Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
* Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
* Patients with constipation secondary to medication use as determined by the study physician
* Patients with clinically significant abnormal TSH levels at screening
* Patients that have heartburn or abdominal pain as their predominant GI symptom
* Evidence of cathartic colon or a history of laxative abuse
* Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00277550
Study Brief:
Protocol Section:
NCT00277550