A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830128
• Other study ID #: A0081209
• Status: Completed
• Phase: Phase 3
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• pregabalin (Lyrica)
Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Hiki-gun	Saitama
Japan	Pfizer Investigational Site	Iiduka	Fukuoka
Japan	Pfizer Investigational Site	Itabashi-Ku	Tokyo
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Kobe	Hyougo
Japan	Pfizer Investigational Site	Matuyama-si	Ehime
Japan	Pfizer Investigational Site	Mito	Ibaraki
Japan	Pfizer Investigational Site	Morioka	Iwate
Japan	Pfizer Investigational Site	Nagano
Japan	Pfizer Investigational Site	Oita
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Saitama-shi	Saitama
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Shimotsuga-gun	Tochigi
Japan	Pfizer Investigational Site	Shinagawa-ku	Tokyo
Japan	Pfizer Investigational Site	Tsu	Mie
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama
Japan	Pfizer Investigational Site	Yotukaidou	Chiba

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 53 weeks
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation
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.	Baseline, Week 52 or Study Discontinuation

External Links

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