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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01812733
Eligibility Criteria:
Inclusion criteria:
* Male or non-pregnant female ≥18 years of age
* Malignant or non-malignant opioid sensitive pain
* Must sign an informed consent form (ICF)
* Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
* Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
* BFI ≥30 and state a discomfort caused by the constipation at screening
* Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months
Exclusion criteria:
* History of, or on-going, abuse of alcohol and/or drugs
* Inability to read and understand written instructions, ICF or questionnaires
* Constipation not related to opioid use
* Unsuitable patient for other reason(s) in the opinion of the investigator
* Inpatients, if admission and/or discharge is expected during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01812733
Study Brief:
Protocol Section:
NCT01812733