NCT03783910

Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia

Cross-over Multiple Dose Study Assessing the Analgesic Efficacy and Safety of Oral GRT9906 Compared to Placebo in Subjects With Primary Fibromyalgia Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study was performed in participants suffering from fibromyalgia and investigated efficacy after treatment with several doses of GRT9906 versus placebo. Furthermore, it was to be found out if treatment with GRT9906 was safe and well-tolerated.

Detailed description

This Phase 2 study had a randomized, multi-center, double-blind, placebo-controlled, crossover, multiple-administration design. The objectives of the study were the following: * To assess the multiple-dose analgesic efficacy and safety of an oral prolonged-release (PR) tablet formulation of GRT9906 at daily doses between 80 and 240 milligrams (mg) in comparison to placebo in participants with moderate to severe pain due to primary fibromyalgia syndrome (FMS). * To compare the tolerability of multiple-dose GRT9906 PR to placebo in participants with primary FMS. * To generate data that could be used, in combination with data from other studies, to explore the population pharmacokinetic analysis and pharmacokinetic/pharmacodynamic (PK/PD) properties of GRT9906 PR. The study consisted of 5 phases: 1. Enrollment including tapering, if necessary, and washout (at least 1 week) of previous medication. 2. First treatment period with 1-week titration and 5-weeks dosing on participant's last well-tolerated titration dosage. 3. Interim washout period of at least 1 week. 4. Second treatment period with 1-week titration and 5-weeks dosing on participant's last well-tolerated titration dosage. 5. Final washout period of at least 1 week, terminated by a Follow-up Visit.

Conditions

• Primary Fibromyalgia

Interventions

Type	Name	Description
DRUG	GRT9906	One prolonged-release tablet containing 40 mg of GRT9906
DRUG	Placebo	Placebo matching GRT9906 tablets

Timeline

• Start date: 2005-09-19
• Primary completion: 2006-10-01
• Completion: 2006-10-20
• First posted: 2018-12-21
• Last updated: 2018-12-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study