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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01443403
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
* Subjects with \< 3 spontaneous bowel movements a week and experiencing bowel symptoms
* Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months
Exclusion Criteria:
* Evidence of clinically significant gastrointestinal disease
* History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation
* Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01443403
Study Brief:
Protocol Section:
NCT01443403