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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01117051
Eligibility Criteria:
Inclusion criteria to be assessed at screening:
1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).
4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.
Main exclusion criteria to be assessed at screening:
1. Constipation is thought to be drug-induced (except for opioids)
2. Disallowed medication is being used
3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
4. Subject is suffering from secondary causes of chronic constipation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01117051
Study Brief:
Protocol Section:
NCT01117051