This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346034
• Other study ID #: A0081101
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• 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 A0081100, 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 A0081100 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
150 to 600mg/day

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Bathurst	New Brunswick
Canada	Pfizer Investigational Site	Drummondville	Quebec
Canada	Pfizer Investigational Site	Hawkesbury	Ontario
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Pointe Claire	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Denmark	Pfizer Investigational Site	Frederiksberg
Denmark	Pfizer Investigational Site	Svendborg
France	Pfizer Investigational Site	Clermont Ferrand Cedex 1
France	Pfizer Investigational Site	Lille	Cedex
France	Pfizer Investigational Site	Montpellier	Cedex 5
France	Pfizer Investigational Site	Paris Cedex 04
France	Pfizer Investigational Site	Saint Priest En Jarez
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Mannheim
Germany	Pfizer Investigational Site	Muenchen
India	Pfizer Investigational Site	Indore	Madhya Pradesh
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Ludhiana	Punjab
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Benevento
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Chieti Scalo
Italy	Pfizer Investigational Site	Pisa
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Suwon-si	Kyeongki-do
Netherlands	Pfizer Investigational Site	Alkmaar
Netherlands	Pfizer Investigational Site	Den Helder
Netherlands	Pfizer Investigational Site	Leeuwarden
Netherlands	Pfizer Investigational Site	Zwolle
Portugal	Pfizer Investigational Site	Lisbon
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Molndal
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Stockholm
Switzerland	Pfizer Investigational Site	Zurich
Switzerland	Pfizer Investigational Site	Zürich
United Kingdom	Pfizer Investigational Site	Greenock	Renfrewshire
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester	Greater Manchester
United Kingdom	Pfizer Investigational Site	North Shields	Tyne And Wear
United Kingdom	Pfizer Investigational Site	Poole

Sponsors (1)

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

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  India,  Italy,  Korea, Republic of,  Netherlands,  Portugal,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score	Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.	Week 4
Primary	Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score	Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.	Week 12 (end of treatment)

External Links

•   To obtain contact information for a study center near you, click here.