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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT00620061
Eligibility Criteria:
Inclusion Criteria:
* Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
* Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
* Willing to continue to abstain from use of disallowed medications as defined per protocol
Exclusion Criteria:
* Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\]
* Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit.
* Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00620061
Study Brief:
Protocol Section:
NCT00620061