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A Study For Pregabalin In Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

pregabalin

placebo

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pregabalin, fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, at least 18 years of age
Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
CLcr less than 60 mL/min (estimated from serum creatinine)

Sites / Locations

Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Anhui Province Hospital
Beijing Chao-Yang Hospital, Capital Medical University
Southwest Hospital of the Third Military Medical University,PLA
Department of Neurology,General Hospital of Guangzhou Military Command of PLA
Guangdong General Hospital
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University
The Third Affiliated Hospital Of Sun Yat-sen University
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University
Xiangya Hospital of Centre-south University
The Second Affiliated Hospital to Nanchang University
Zhongshan Hospital Fudan University, Rheumatology Department
Xijing Hospital, The Fourth Military Medical University
Si Chuan Huaxi Hospital/Rheumatology Department
The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department
The First Affiliated Hospital of Wenzhou Medical University/Neurology Department
China-Japan Friendship Hospital/Rheumatology Department
Peking Union Medical College Hospital/Rheumatology Department
PLA. The Military General Hospital of Beijing
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
Rheumatology and Immunology Department, Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

Matched placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.

Secondary Outcome Measures

Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14

The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14

The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment.

Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.

Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute.

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.

Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale

Change From Baseline in Mean Sleep Interference Score at Week 14

The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1.

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14

The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment.

Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score

The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status.

Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score

The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.

Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14

The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 "no pain" to 100 "worst possible pain".

Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score

The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment.

Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score

The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs.

Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity

A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function.

Full Information

NCT ID

NCT01387607

First Posted

June 30, 2011

Last Updated

January 26, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01387607

Brief Title

A Study For Pregabalin In Patients With Fibromyalgia

Official Title

A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 6, 2012 (Actual)

Primary Completion Date

October 31, 2016 (Actual)

Study Completion Date

October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Pregabalin, fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched placebo

Intervention Type

Drug

Intervention Name(s)

pregabalin

Intervention Description

Pregabalin capsule, 300-450mg/day, twice daily

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo, twice daily

Primary Outcome Measure Information:

Title

Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14

Description

Time Frame

Baseline, Week 14

Secondary Outcome Measure Information:

Title

Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14

Description

Time Frame

Week 14

Title

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14

Description

Time Frame

Baseline, Week 14

Title

Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14

Description

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.

Time Frame

Baseline, Week 14

Title

Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14

Description

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores

Description

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores

Description

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score

Description

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.

Time Frame

Baseline, Week 14

Title

Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline in Mean Sleep Interference Score at Week 14

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)

Description

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)

Description

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)

Description

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality

Description

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Time Frame

Baseline, Week 14

Title

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score

Description

The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.

Time Frame

Baseline, Week 14

Title

Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14

Description

The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 "no pain" to 100 "worst possible pain".

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score

Description

The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.

Time Frame

Baseline, Week 14

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs

Description

Time Frame

Baseline to Follow up (Day 105)

Title

Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity

Description

Time Frame

Baseline to Follow up (Day 105)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, at least 18 years of age Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS) At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4 Exclusion Criteria: Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1) Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders CLcr less than 60 mL/min (estimated from serum creatinine)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College

City

Bengbu

State/Province

Anhui

ZIP/Postal Code

233000

Country

China

Facility Name

Anhui Province Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Facility Name

Beijing Chao-Yang Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Southwest Hospital of the Third Military Medical University,PLA

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

Department of Neurology,General Hospital of Guangzhou Military Command of PLA

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510010

Country

China

Facility Name

Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

The Third Affiliated Hospital Of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Facility Name

Rheumatology Department, The first Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150001

Country

China

Facility Name

Rheumatology Department, The second Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150086

Country

China

Facility Name

Xiangya Hospital of Centre-south University

City

Changsha, Kaifu District

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Facility Name

The Second Affiliated Hospital to Nanchang University

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Zhongshan Hospital Fudan University, Rheumatology Department

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Xijing Hospital, The Fourth Military Medical University

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Si Chuan Huaxi Hospital/Rheumatology Department

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650032

Country

China

Facility Name

The First Affiliated Hospital of Wenzhou Medical University/Neurology Department

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Facility Name

China-Japan Friendship Hospital/Rheumatology Department

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

Peking Union Medical College Hospital/Rheumatology Department

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

PLA. The Military General Hospital of Beijing

City

Beijing

ZIP/Postal Code

100700

Country

China

Facility Name

Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine

City

Shanghai

ZIP/Postal Code

200001

Country

China

Facility Name

Rheumatology and Immunology Department, Shanghai Changzheng Hospital

City

Shanghai

ZIP/Postal Code

200003

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33658841

Citation

Zhang X, Xu H, Zhang Z, Li Y, Pauer L, Liao S, Zhang F. Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects. J Pain Res. 2021 Feb 25;14:537-548. doi: 10.2147/JPR.S281483. eCollection 2021.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081241&StudyName=A%20Study%20For%20Pregabalin%20In%20Patients%20With%20Fibromyalgia%20

Description

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Learn more about this trial

A Study For Pregabalin In Patients With Fibromyalgia

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