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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01901718
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age.
* Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days.
* Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment.
* Are able to follow and complete all necessary study procedures.
* Are willing and able to give written informed consent before participating in the study.
* Enrolled in the class wide REMS as verified by the study personnel.
Exclusion Criteria:
* Subjects who are not opioid tolerant.
* Using a rapid onset opioid other than Actiq® to manage their breakthrough pain.
* Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator.
* Are subjects with uncontrolled or rapidly escalating pain.
* Are subjects with a history of alcohol or substance abuse within the last 3 years.
* Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject.
* Are subjects who have participated in another clinical trial with an analgesic within the last month.
* Are female subjects with a positive pregnancy test or who are currently lactating.
* Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole.
* Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication.
* Opioid being used for chronic migraine or acute pain.
* Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01901718
Study Brief:
Protocol Section:
NCT01901718