The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02868814
• Other study ID #: HR-PRBL-FM
• Status: Recruiting
• Phase: Phase 3
• First received: July 29, 2016
• Last updated: August 11, 2016
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: July 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).

Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been =4, and had a score of =40 mm on the Visual Analogue Scale (VAS) at screening and randomization .

Exclusion Criteria:

• Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.

Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Pregabalin Release Tablets

• Pregabalin Release Tablets

• Placebo

Locations

Country	Name	City	State
China	Xiehe Hospital of Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean pain score diary at Endpoint	derived from the subject's daily pain	Baseline and 15 weeks	No
Secondary	Change from baseline in FIQ scores at Weeks 15		Baseline and Weeks 15	No
Secondary	Change from baseline in SF-36 scores at Weeks 15		Baseline and Weeks 15	No
Secondary	Change from baseline in HADS scores at Weeks 15		Baseline and Weeks 15	No
Secondary	Change from baseline in MOS-SS scores at Weeks 15		Baseline and Weeks 15	No
Secondary	Quality of Sleep Score from the Daily Sleep Diary		up to 15 weeks	No
Secondary	Mean pain score from the subject's daily pain		up to 15 weeks	No