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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT00597428
Eligibility Criteria:
Inclusion Criteria:
* Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
* Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
* If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
* Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
* If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
* Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.
Exclusion Criteria:
* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
* Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
* Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
* Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00597428
Study Brief:
Protocol Section:
NCT00597428