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Search / Trial NCT01387607

A Study For Pregabalin In Patients With Fibromyalgia

Launched by PFIZER'S UPJOHN HAS MERGED WITH MYLAN TO FORM VIATRIS INC. · Jun 30, 2011

Trial Information

Current as of June 01, 2025

Completed

Keywords

Pregabalin Fibromyalgia

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female patients, at least 18 years of age
  • Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
  • At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
  • Exclusion Criteria:
  • Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
  • Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
  • CLcr less than 60 mL/min (estimated from serum creatinine)

About Pfizer's Upjohn Has Merged With Mylan To Form Viatris Inc.

Viatris Inc. is a global healthcare company formed from the merger of Pfizer's Upjohn division and Mylan, dedicated to providing access to high-quality medicines, including generics and specialty pharmaceuticals. With a strong commitment to innovation and patient-centric solutions, Viatris leverages a diverse portfolio and extensive global reach to address the evolving healthcare needs of patients worldwide. The company aims to create sustainable healthcare solutions by combining expertise in pharmaceutical development, manufacturing, and distribution, ultimately enhancing patient outcomes and improving overall health systems.

Locations

Guangzhou, Guangdong, China

Shanghai, , China

Guangzhou, Guangdong, China

Bengbu, Anhui, China

Hefei, Anhui, China

Beijing, Beijing, China

Chongqing, Chongqing, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Harbin, Heilongjiang, China

Harbin, Heilongjiang, China

Changsha, Kaifu District, Hunan, China

Nanchang, Jiangxi, China

Shanghai, Shanghai, China

Xi'an, Shanxi, China

Chengdu, Sichuan, China

Kunming, Yunnan, China

Wenzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Beijing, , China

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Pfizer CT.gov Call Center

Study Director

Pfizer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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