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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT00669461
Eligibility Criteria:
Inclusion Criteria:
1. Age 50-85 years
2. Diagnosis of Parkinson's disease
3. Constipation as defined by the Rome III committee
4. BSFS of more or equal to 1 and less or equal to 3
5. Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
6. All women subjects will be post menopausal or surgically sterile.
Exclusion Criteria:
1. Known hypersensitivity reaction to Amitiza ( Lubiprostone)
2. Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
3. Renal dysfunction with creatinine clearance less than 15 ml/min
4. Abnormal liver enzymes or history of chronic liver disorder
5. History of bowel obstruction, , or abdominal adhesions .
6. Abnormal Colonoscopy ( obstructive lesions within the colon)
7. Inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT00669461
Study Brief:
Protocol Section:
NCT00669461