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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT01517295
Eligibility Criteria:
Inclusion Criteria:
* Man or woman aged 18-75
* Documented clinical diagnosis of chronic pain.
* Have been taking hydrocodone/APAP for their chronic non-cancer pain.
* Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
* Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
* Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
* Health concerns that the study physician feels may confound study results.
* Individuals who are cognitively impaired or who are not able to give informed consent.
* Previous participation in a clinical research trial within 30 days prior to randomization.
* The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01517295
Study Brief:
Protocol Section:
NCT01517295