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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Pregabalin Release Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02868814

HR-PRBL-FM

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 3 patient groups, including a placebo group

330mg/day

Experimental group

Description:

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)

Treatment:

Drug: Pregabalin Release Tablets

Drug: Pregabalin Release Tablets

495mg/day

Experimental group

Description:

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)

Treatment:

Drug: Pregabalin Release Tablets

Drug: Pregabalin Release Tablets

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo