Fibromyalgia
Conditions
Brief summary
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
Interventions
Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.
Exclusion criteria
* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 53 weeks | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Baseline, Week 52 or Study Discontinuation | The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | Week 52 or Study Discontinuation | MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \< 7 hours per night. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint | Baseline, Week 52 or Study Discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Baseline, Week 52 or Study Discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
Countries
Japan
Participant flow
Pre-assignment details
Participants received the study drug in the precedent study A0081208 (NCT00830167).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Family obligation | 1 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Operating a vehicle | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Relocation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
| Overall Study | Work obligation | 1 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Customized <18 years | 0 Participants |
| Age, Customized >= 65 years | 10 Participants |
| Age, Customized Between 18 and 44 years | 47 Participants |
| Age, Customized Between 45 and 64 years | 49 Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 92 / 106 |
| serious Total, serious adverse events | 3 / 106 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Time frame: Up to 53 weeks
Population: All participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | All-causality adverse events (AEs) | 102 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | All-causality SAEs | 3 Participants |
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Physical Functioning | -0.2 Units on a scale | Standard Deviation 2 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Feel Good | -0.4 Units on a scale | Standard Deviation 2.7 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Work Missed | -0.5 Units on a scale | Standard Deviation 2.8 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Difficulty Working | -0.7 Units on a scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Pain | -1.0 Units on a scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Fatigue | -0.3 Units on a scale | Standard Deviation 1.9 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Morning Tiredness | -0.6 Units on a scale | Standard Deviation 2.2 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Stiffness | -0.7 Units on a scale | Standard Deviation 2.5 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Anoxiouness | -0.3 Units on a scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Depression | -0.2 Units on a scale | Standard Deviation 2.6 |
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint | -4.9 Units on a scale | Standard Deviation 17.2 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | -3.0 Units on a scale | Standard Deviation 23.1 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | -3.7 Units on a scale | Standard Deviation 15.7 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | 0.3 hours | Standard Deviation 1.2 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | 4.2 Units on a scale | Standard Deviation 21.3 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | -9.6 Units on a scale | Standard Deviation 23.3 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | 1.9 Units on a scale | Standard Deviation 22.3 |
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | 7.2 Units on a scale | Standard Deviation 24 |
Secondary
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 52 or Study Discontinuation
Population: All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | -13.1 mm | Standard Deviation 25.3 |
Secondary
Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \< 7 hours per night.
Time frame: Week 52 or Study Discontinuation
Population: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | Yes | 26 Paticipants |
| Pregabalin | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | No | 80 Paticipants |