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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT07186751
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
* Aged 18 years or older;
* Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
* Numeric rating scale (NRS) score ≥ 4 at baseline;
* Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
* Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
* Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Exclusion criteria
* History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
* History of epilepsy, or depression requiring antidepressant medications;
* Pregnancy or breastfeeding;
* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
* With acute or chronic pain conditions other than FM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07186751
Study Brief:
Protocol Section:
NCT07186751