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Recruiting NCT07186751

The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia

No phase Interventional Fibromyalgia Pregabalin Venlafaxine Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregabalin, Pregabalin with venlafaxine.
Who it may be relevant to
Registry conditions: Fibromyalgia, Pregabalin, Venlafaxine, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Overview

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 neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Interventions

  • Drug Pregabalin
    In general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg/day, administered in two divided doses. After 7 days, the dose will be increased to 300 mg/day. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg/day.
  • Drug Pregabalin with venlafaxine
    For the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg/day. If well-tolerated, the dose may be increased in 75 mg/day increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg/day.

Primary outcome measures

  • The average pain intensity [Time frame: At the 4-weeks]
Secondary outcome measures (9)
  • The worst pain intensity [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The proportion of patients achieving pain reduction [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • Dose of pregabalin and/or venlafaxine [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The Revised FM Impact Questionnaire [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The short-form 36 Health Survey (SF-36) [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The Medical Outcomes Study Sleep Scale (MOS) [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • The Beck Depression Inventory-Ⅱ (BD-Ⅱ) [Time frame: At the weeks 1, 2, 4, 8, and 12]
  • Adverse Events [Time frame: Through study completion, an average of 12 weeks]

Eligibility criteria

Inclusion criteria

  • Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
  • Aged more than 18 years;
  • Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
  • Agreed to sign the informed consent form.

Exclusion criteria

  • A history of psychiatric disease;
  • Hypersensitivity or have contraindications to pregabalin, venlafaxine;
  • Pregnancy or breastfeeding;
  • Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;
  • With acute or chronic pain conditions other than FM.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijin
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07186751 · KY2025-217-03-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗