CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 129 enrolled
Drug / intervention
Sodium Oxybate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803023
NCT00803023Phase 3Completed
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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

Jazz Pharmaceuticals·interventional·Posted Dec 5, 2008·Updated Aug 19, 2011

In Brief

A Phase 3 clinical trial evaluating Sodium Oxybate, Sodium Oxybate & 6 Tablets, and 2 other interventions for Fibromyalgia. Completed, enrolled 129 participants across 32 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.6 years ago

Interventions

Sodium Oxybatedrug

4.5 grams per night taken in two equally divided doses

Sodium Oxybate & 6 Tabletsdrug

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

Sodium Oxybate & 8 Tabletsdrug

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

Sodium Oxybate Oral Solution (6 grams)drug

6 grams per night taken in two equally divided doses