Status:
RECRUITING
The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
China-Japan Friendship Hospital
First Affiliated Hospital of Army Medical University, PLA
Conditions:
Fibromyalgia
Pregabalin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07186751
Start Date
September 20 2025
End Date
August 31 2027
Last Update
December 8 2025
Active Locations (2)
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1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijin, China
2
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China