Pregabalin plus desvenlafaxine for fibromyalgia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will compare pregabalin alone to pregabalin combined with desvenlafaxine in adults with moderate to severe fibromyalgia. Participants meeting the 2016 fibromyalgia diagnostic criteria and a baseline pain NRS ≥4 will be enrolled and assigned to one of the two medication regimens. Outcomes include measures of pain relief and monitoring for adverse effects, with laboratory checks for liver and kidney function. The trial aims to determine if adding desvenlafaxine, an SNRI with a potentially lower side-effect profile, increases the proportion of patients achieving meaningful pain reduction.

Why it matters

Who can join: the full rules

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, desvenlafaxine 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.

Where it's running

• Beijing Tiantan Hospital, Beijing, Beijing 100070
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Luo, M.D.
• Email: 13611326978@163.com
• Phone: +86 13611326978

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pregabalin plus venlafaxine for fibromyalgia pain

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• Respiratory Function in Fibromyalgia: A Look at Breath and Muscle Health in Women

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.