An interventional study of Pregabalin and Pregabalin with venlafaxine in Fibromyalgia, Pregabalin and Venlafaxine, sponsored by Beijing Tiantan Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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Among 30 studies testing pregabalin in Fibromyalgia — 6 open to participants now, 6 under way, none of them phase 3. Pregabalin · Fibromyalgia.
Among the 30 studies testing pregabalin in Fibromyalgia, this one is the 3rd largest by planned enrollment, is one of 4 that started in 2025, is one of 9 with no phase, and was the 27th registered.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →6 of the 30 studies testing pregabalin in Fibromyalgia are open now, in 2 countries. Recruiting first, the newest first:
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18–65
Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Sites in Turkey
Ages 20–50 · Women only · Healthy volunteers
By country, each count listing its studies:
Pregabalin: first FDA approval 2004 (LYRICA), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 14 · Phase 4 7
First in 2004; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 750 is above the median of 60 across 938 interventional studies indexed under Fibromyalgia.
Median enrollment 199 across the 30 interventional studies. Of the 22 that completed or were terminated, 10 (45%) have results posted.
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16 of 30 have an industry lead sponsor. The 10 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 491 studies on the registry; 295 are open to participants now.
Beijing Tiantan Hospital has 9 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
4 of the studies testing pregabalin in Fibromyalgia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07186751Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia | 2027-06-30 |
| NCT07230197Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia | 2027-06-30 |
| NCT07208357Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia | 2027-06-30 |
| NCT07171320Beijing Tiantan HospitalThe Efficacy and Safety of Pregabalin Combined With Desvenlafaxine in Patients With Fibromyalgia | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 30 studies testing pregabalin in Fibromyalgia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pregabalin
Drug: Pregabalin with venlafaxine
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 pages: Pregabalin · 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.
The average pain intensity
The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: At the 4-weeks
The worst pain intensity
The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: At the weeks 1, 2, 4, 8, and 12
The proportion of patients achieving pain reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: At the weeks 1, 2, 4, 8, and 12
Dose of pregabalin and/or venlafaxine
At the aforementioned follow-up time points, the researchers will inquire about the current dosages of pregabalin and/or venlafaxine being administered to the participants. Any dose adjustments, interruptions, or discontinuations, along with the reasons will be documented in detail.
Time frame: At the weeks 1, 2, 4, 8, and 12
The Revised FM Impact Questionnaire
The Revised FM Impact Questionnaire assesses the severity of FM symptoms and their impact on daily functioning. It evaluates three linked domains: function, overall impact, and symptoms, using a 0 to10 NRS. The total score ranges from 0 to 100, with higher scores indicating greater disease burden.
Time frame: At the weeks 1, 2, 4, 8, and 12
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
BPI-S accesses pain intensity over the past 24 hours, calculated as the average of items 3 to 6 on the BPI, scored using a 0 to 10 NRS. In the NRS scale, 0 indicates no pain, while 10 represents the worst pain imaginable. The total score ranges from 0 to 40, with higher scores indicating greater pain severity. BPI-I evaluates the degree to which pain interferes with daily activities, including general activity, mood, mobility work, relationships, sleep, and pleasure. This subscale comprises 7 items, each scored from 0 (no interference) to 10 (complete interference), with a total score ranging from 0 to 70.
Time frame: At the weeks 1, 2, 4, 8, and 12
The short-form 36 Health Survey (SF-36)
The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.
Time frame: At the weeks 1, 2, 4, 8, and 12
The Medical Outcomes Study Sleep Scale (MOS)
The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).
Time frame: At the weeks 1, 2, 4, 8, and 12
The Beck Depression Inventory-Ⅱ (BD-Ⅱ)
The BD-Ⅱ evaluates the severity of depressive symptoms using a 4-point scale from 0 to 3, where 0 indicates no symptom and 3 indicates severe symptomatology. It comprises 21 items, the total score ranging from 0 to 63.
Time frame: At the weeks 1, 2, 4, 8, and 12
Adverse Events
The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.
Time frame: Through study completion, an average of 12 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Started Sep 2025 (actual). Primary completion is estimated for Jun 2027, 21 months after the start.
Of 438 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 21 months is above that.
Counting every sponsor, half of 451 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Pregabalin · Venlafaxine