Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental |
| |
| Placebo | Placebo Comparator | Matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | Pregabalin capsule, 300-450mg/day, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33658841 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
A total of 431 participants were screened and 343 of these were randomized. A total of 334 participants received the assigned study treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. |
| FG001 | Placebo | Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
Baseline to Follow up (Day 105)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
Placebo, twice daily |
|
| Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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". | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline, Week 14 |
| 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. | Baseline to Follow up (Day 105) |
| 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. | Baseline to Follow up (Day 105) |
| Anhui Province Hospital |
| Hefei |
| Anhui |
| 230001 |
| China |
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
| Southwest Hospital of the Third Military Medical University,PLA | Chongqing | Chongqing Municipality | 400038 | China |
| Department of Neurology,General Hospital of Guangzhou Military Command of PLA | Guangzhou | Guangdong | 510010 | China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital Of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| Rheumatology Department, The first Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Rheumatology Department, The second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
| Xiangya Hospital of Centre-south University | Changsha, Kaifu District | Hunan | 410008 | China |
| The Second Affiliated Hospital to Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Zhongshan Hospital Fudan University, Rheumatology Department | Shanghai | Shanghai Municipality | 200032 | China |
| Xijing Hospital, The Fourth Military Medical University | Xi’an | Shanxi | 710032 | China |
| Si Chuan Huaxi Hospital/Rheumatology Department | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department | Kunming | Yunnan | 650032 | China |
| The First Affiliated Hospital of Wenzhou Medical University/Neurology Department | Wenzhou | Zhejiang | 325000 | China |
| China-Japan Friendship Hospital/Rheumatology Department | Beijing | 100029 | China |
| Peking Union Medical College Hospital/Rheumatology Department | Beijing | 100032 | China |
| PLA. The Military General Hospital of Beijing | Beijing | 100700 | China |
| Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | 200001 | China |
| Rheumatology and Immunology Department, Shanghai Changzheng Hospital | Shanghai | 200003 | China |
| Lost to Follow-up |
|
| No longer meets eligibility criteria |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| Randomized, not treated |
|
| BG001 | Placebo | Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary Diagnoses and Durations | Mean | Standard Deviation | years |
|
Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.
Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.
| OG001 | Placebo | Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. |
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Number | Percentage of participants | Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Number | Percentage of participants | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Number | Percentage of participants | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Number | Percentage of participants | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Minutes | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Minutes | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Awakenings | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Minutes | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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". | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 14 |
|
|
|
|
| Secondary | 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. | The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline to Follow up (Day 105) |
|
|
|
| Secondary | 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. | The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Number | Events | Baseline to Follow up (Day 105) |
|
|
|
| 0 |
| 170 |
| 88 |
| 170 |
| EG001 | Placebo | Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. | 9 | 164 | 47 | 164 |
| Goitre | Endocrine disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Cerebral haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009422 |
| Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other. | Cochran-Mantel-Haenszel | 0.1510 | Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center. | Odds Ratio (OR) | 1.4626 | 2-Sided | 95 | 0.8596 | 2.4886 | Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo. | Superiority or Other (legacy) |
| Sleep Adequacy |
|
Statistical analysis for awaken short of breath. |
| ANCOVA |
| 0.2993 |
From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate. |
| Mean Difference (Final Values) |
| -2.355 |
| Standard Error of the Mean |
| 2.2650 |
| 2-Sided |
| 95 |
| -6.81 |
| 2.10 |
| Superiority or Other (legacy) |
| Statistical analysis for sleep adequacy. | ANCOVA | 0.0003 | From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate. | Mean Difference (Final Values) | 9.030 | Standard Error of the Mean | 2.4485 | 2-Sided | 95 | 4.21 | 13.85 | Superiority or Other (legacy) |
Statistical analysis for somnolence |
| ANCOVA |
| 0.0112 |
From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate. |
| Mean Difference (Final Values) |
| 4.194 |
| Standard Error of the Mean |
| 1.6428 |
| 2-Sided |
| 95 |
| 0.96 |
| 7.43 |
| Superiority or Other (legacy) |
| Discontinuation due to AEs |
|
| Severe AEs |
|