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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT00472303
Eligibility Criteria:
Inclusion Criteria
* Male and non-pregnant, non-lactating female subjects.
* Of at least 18 years of age with chronic malignant tumor-related pain with a mean pain intensity (NRS) of 5 points or higher.
* Subjects who are opioid-naïve or pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
* Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the trial.
* Expected course of the disease and the pain that would permit compliance with the trial protocol over the entire trial period.
Exclusion Criteria
Key Exclusion Criteria:
* Subjects will be excluded from the study if they have a history of seizure disorder or epilepsy;
* known history and/or presence of cerebral tumor or cerebral metastases.
* history of alcohol or drug abuse;
* uncontrolled hypertension,
* clinical laboratory values reflecting severe renal insufficiency,
* moderate or severe hepatic impairment,
* hepatitis B or C, HIV,
* inadequate bone marrow reserve
* currently treated with radiotherapy,
* pain-inducing chemotherapy,
* anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial.
* selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00472303
Study Brief:
Protocol Section:
NCT00472303