FibromyalgiaNCT07186751
The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
A study testing Pregabalin and Pregabalin with venlafaxine in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 2 sites in China.
Trial 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 neurotransmitters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Pregabalin, Venlafaxine
- What is being tested?
- Pregabalin and Pregabalin with venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesChina
- Study dates
- 20 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijin
- Recruiting
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing
Fang Luo, +8613611326978, 13611326978@163.com
About this study
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
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.
- Conditions
- Fibromyalgia, Pregabalin, Venlafaxine, Pain
- Being tested
- Pregabalin, Pregabalin with venlafaxine
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
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.
Pregabalin with venlafaxineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin monotherapy group | Active comparator | Not described Receives: Drug: Pregabalin |
| Pregabalin with venlafaxine group | Experimental | Not described Receives: Drug: Pregabalin with venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the 4-weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start20 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Second Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Nanchang University, Yangyuan Youyi Hospital, Yanbian University Hospital, Beijing Rehabilitation Hospital, Three Gorges Hospital of Chongqing University, Beijing Sanbo Brain Hospital, General Hospital of Ningxia Medical University, The First People's Hospital of Yunnan, Guangdong Provincial Hospital of Chinese Medicine, Zhuhai, The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186751
- Sponsor's protocol ID
- KY2025-217-03-03
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07186751
- Acronym / sponsor ID
- KY2025-217-03-03
- Conditions
- Fibromyalgia, Pregabalin, Venlafaxine, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Second Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Nanchang University, Yangyuan Youyi Hospital, Yanbian University Hospital, Beijing Rehabilitation Hospital, Three Gorges Hospital of Chongqing University, Beijing Sanbo Brain Hospital, General Hospital of Ningxia Medical University, The First People's Hospital of Yunnan, Guangdong Provincial Hospital of Chinese Medicine, Zhuhai, The First Affiliated Hospital of Anhui Medical University
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin monotherapy group | Active comparator | Drug: Pregabalin |
| Pregabalin with venlafaxine group | Experimental | Drug: Pregabalin with venlafaxine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinIn 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 monotherapy group |
| Pregabalin with venlafaxineFor 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. | Drug | Pregabalin with venlafaxine group |
Primary outcome
The average pain intensity
Time frame: At the 4-weeks
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315Link provided by the sponsor.
- Migliorini F, Maffulli N, Eschweiler J, Baroncini A, Bell A, Colarossi G. Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):504. doi: 10.1186/s13018-023-03995-z.Link provided by the sponsor.
- Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.Link provided by the sponsor.
- VanderWeide LA, Smith SM, Trinkley KE. A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia. J Clin Pharm Ther. 2015;40(1):1-6. doi: 10.1111/jcpt.12216.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Pregabalin with venlafaxine in people with Fibromyalgia and Pregabalin, run by Beijing Tiantan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (+8613611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average pain intensity (time frame: At the 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.