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

Phase 3

• Conditions: Fibromyalgia
• Interventions: Drug: Pregabalin Release Tablets; Drug: Placebo

• Registration Number: NCT02868814
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-11
• Last Update Submitted: 2016-08-11
• Study First Posted: 2016-08-16
• Last Update Posted: 2016-08-16
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
330mg/day	Pregabalin Release Tablets	330 mg QD taken orally,1 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
495mg/day	Pregabalin Release Tablets	495 mg QD taken orally,2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Placebo	Placebo	1 or 2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean pain score diary at Endpoint	Baseline and 15 weeks	derived from the subject's daily pain

Secondary Outcome Measures

Name	Time	Method
Quality of Sleep Score from the Daily Sleep Diary	up to 15 weeks
Mean pain score from the subject's daily pain	up to 15 weeks
Change from baseline in FIQ scores at Weeks 15	Baseline and Weeks 15
Change from baseline in HADS scores at Weeks 15	Baseline and Weeks 15
Change from baseline in SF-36 scores at Weeks 15	Baseline and Weeks 15
Change from baseline in MOS-SS scores at Weeks 15	Baseline and Weeks 15

Trial Locations

Locations (1)

Xiehe Hospital of Beijing; 🇨🇳 Beijing, Beijing, China