FibromyalgiaPhase 3NCT00830128
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
A Phase 3 study testing pregabalin (Lyrica) in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 19 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- pregabalin (Lyrica)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 19 sitesJapan
- Study dates
- Jul 2009to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Hiki-gun, Saitama
Pfizer Investigational Site
Iiduka, Fukuoka
Pfizer Investigational Site
Itabashi-Ku, Tokyo
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Matuyama-si, Ehime
Pfizer Investigational Site
Mito, Ibaraki
Pfizer Investigational Site
Morioka, Iwate
Pfizer Investigational Site
Nagano
Pfizer Investigational Site
Ōita
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Saitama-shi, Saitama
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Shimotsuga-gun, Tochigi
Pfizer Investigational Site
Shinagawa-ku, Tokyo
Pfizer Investigational Site
Tsu, Mie-ken
Pfizer Investigational Site
Yokohama, Kanagawa
Pfizer Investigational Site
Yokohama
Pfizer Investigational Site
Yotukaidou, Chiba
About this study
Official title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia
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).
- Conditions
- Fibromyalgia
- Being tested
- pregabalin (Lyrica)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin (Lyrica)Drug
Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| pregabalin (Lyrica) | Experimental | Not described Receives: Drug: pregabalin (Lyrica) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 53 weeks
Secondary outcomes (11)
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
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.
Measured: Baseline, Week 52 or Study Discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830128
- Sponsor's protocol ID
- A0081209
- Status last verified
- Apr 2012
- First submitted
- 26 Jan 2009
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00830128
- Acronym / sponsor ID
- A0081209
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 14 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregabalin (Lyrica) | Experimental | Drug: pregabalin (Lyrica) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalin (Lyrica)Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks | Drug | pregabalin (Lyrica) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
11 secondary outcomes
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint
Time frame: Week 52 or Study Discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Time frame: Baseline, Week 52 or Study Discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin (Lyrica) in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 19 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 53 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.