Clinical trial NCT00830128: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Official title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 53 weeks
Secondary outcomes:
measure: Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint
timeFrame: Week 52 or Study Discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
timeFrame: Baseline, Week 52 or Study Discontinuation
Other outcomes:
Locations:
city: Yotukaidou
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matuyama-si
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Iiduka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Mito
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Morioka
country: Japan
facility: Pfizer Investigational Site
state: Iwate
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Tsu
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Hiki-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Shimotsuga-gun
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Itabashi-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nagano
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: