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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT01008618
Eligibility Criteria:
Inclusion Criteria:
* Participants whose pain because of osteoarthritis or low back pain is continuing for at least 12 weeks prior to informed consent
* Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or participant at a certain dose (except the use on an as-needed base) on consecutive days
* Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and requiring a continuous opioid analgesic as per the investigator or sub-investigator
* Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale (VAS) in 24-hour daily living prior to informed consent
* Participants who can be hospitalized to the 4th day after the initiation of titration period
Exclusion Criteria:
* In cases of low back pain, participants with severe pain of lower extremities due to radiculopathy (a problem in which one or more nerves are affected) than that of low back pain, or participants with disc herniation (a medical condition affecting the spine due to trauma, lifting injuries, or idiopathic \[unknown\] causes) requiring an operation
* In cases of low back pain, participants with pain due to compression fracture
* Participants who had an operation that may affect the assessment within 30 days before informed consent
* Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
* Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01008618
Study Brief:
Protocol Section:
NCT01008618