Clinical trial NCT01387607: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Pregabalin
fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14
timeFrame: Baseline, Week 14
Secondary outcomes:
measure: Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14
timeFrame: Week 14
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14
timeFrame: Baseline, Week 14
measure: Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14
timeFrame: Baseline, Week 14
measure: Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score
timeFrame: Baseline, Week 14
measure: Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale
timeFrame: Baseline, Week 14
measure: Change From Baseline in Mean Sleep Interference Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality
timeFrame: Baseline, Week 14
measure: Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score
timeFrame: Baseline, Week 14
measure: Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
timeFrame: Baseline, Week 14
measure: Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
timeFrame: Baseline, Week 14
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
timeFrame: Baseline to Follow up (Day 105)
measure: Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity
timeFrame: Baseline to Follow up (Day 105)
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital of the Third Military Medical University,PLA
state: Chongqing
city: Guangzhou
country: China
facility: Department of Neurology,General Hospital of Guangzhou Military Command of PLA
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-sen University
state: Guangdong
city: Harbin
country: China
facility: Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Rheumatology Department, The second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha, Kaifu District
country: China
facility: Xiangya Hospital of Centre-south University
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University, Rheumatology Department
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Si Chuan Huaxi Hospital/Rheumatology Department
state: Sichuan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department
state: Yunnan
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University/Neurology Department
state: Zhejiang
city: Beijing
country: China
facility: China-Japan Friendship Hospital/Rheumatology Department
city: Beijing
country: China
facility: Peking Union Medical College Hospital/Rheumatology Department
city: Beijing
country: China
facility: PLA. The Military General Hospital of Beijing
city: Shanghai
country: China
facility: Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.