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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01124604
Eligibility Criteria:
Inclusion Criteria:
* Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
* Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
* Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
* Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
* Participants who are able to visit the medical institutions throughout the study period
Exclusion Criteria:
* Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
* Participants with current or a history of epilepsy or seizure disorders
* Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
* Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
* Participants with moderate to severe liver dysfunction or severe renal dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01124604
Study Brief:
Protocol Section:
NCT01124604