Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia
NCT03783910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2018-12-21
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.
Conditions
- Primary Fibromyalgia
Interventions
- DRUG
-
GRT9906
One prolonged-release tablet containing 40 mg of GRT9906
- DRUG
-
Placebo matching GRT9906 tablets
Sponsors & Collaborators
-
Grünenthal GmbH
lead INDUSTRY
Principal Investigators
-
Grünenthal Study Director · Grünenthal GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-09-19
- Primary Completion
- 2006-10-31
- Completion
- 2006-10-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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