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NCT00803023 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
129
Enrollment target

NCT00803023 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 129 participants.

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The verdict

NCT00803023, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
129 participants
Enrollment target

Study 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).

Interventions

  • DRUG Sodium Oxybate
  • DRUG Sodium Oxybate & 6 Tablets
  • DRUG Sodium Oxybate & 8 Tablets
  • DRUG Sodium Oxybate Oral Solution (6 grams)

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2010-03
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

128 total trials

What the Registry Record Tells You About NCT00803023

The ClinicalTrials.gov registry entry for NCT00803023 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Sodium Oxybate is the first listed.

NCT00803023 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00803023 about?

NCT00803023 is a clinical study titled "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". 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).

What is the current status of trial NCT00803023?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2010-03.

What interventions are being tested in trial NCT00803023?

The interventions under investigation include: Sodium Oxybate (DRUG), Sodium Oxybate & 6 Tablets (DRUG), Sodium Oxybate & 8 Tablets (DRUG), Sodium Oxybate Oral Solution (6 grams) (DRUG).

Who is sponsoring clinical trial NCT00803023?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.