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Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

NCT00803023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2011-08-19

Study results available
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Summary

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Conditions

  • Fibromyalgia

Interventions

DRUG

Sodium Oxybate

4.5 grams per night taken in two equally divided doses

DRUG

Sodium Oxybate & 6 Tablets

4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night

DRUG

Sodium Oxybate & 8 Tablets

6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night

DRUG

Sodium Oxybate Oral Solution (6 grams)

6 grams per night taken in two equally divided doses

Sponsors & Collaborators

Principal Investigators

  • Grace Wang, MD · Jazz Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00803023 on ClinicalTrials.gov