FibromyalgiaPhase 3NCT00803023

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 testing Sodium Oxybate, Sodium Oxybate & 6 Tablets and Sodium Oxybate & 8 Tablets in people with Fibromyalgia, run by Jazz Pharmaceuticals at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia
What is being tested?: Sodium Oxybate, Sodium Oxybate & 6 Tablets and Sodium Oxybate & 8 Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 32 sitesUnited States
Study dates: Mar 2010to Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is able to understand the written informed consent
Subject is 18 years of age or older.
Subject meets the ACR criteria for fibromyalgia
Subject is willing to discontinue prohibited by the protocol
Subject agrees to use only non-sedating over-the-counter (OTC)medication
Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.

Who cannot join

Subject has protocol prohibited medical \& psychiatric conditions that would exclude subject
Subject has a current or past history of a substance use disorder including alcohol abuse
Subject has a clinically significant history of seizure disorder either past or present
Female subject who is pregnant, nursing or lactating.
Subject is diagnosed with sleep apnea
Subject is unable to discontinue protocol prohibited medications

Show all 14Show fewer

Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
Subject is on a sodium-restricted diet.
Subject has abnormal liver function test or other abnormal lab values
Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Advanced Clinical Research Institute
Anaheim, California, 92801
Orange County Clinical Trials
Anaheim, California, 92801
FutureSearch Trials of Neurology
Austin, Texas, 78756
Louisiana Sleep Foundation
Baton Rouge, Louisiana, 70809
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
Clinsearch
Chattanooga, Tennessee, 37421
Hill Top Physicians Inc. / Hihgtop Medical Research Center
Cincinnati, Ohio, 45224
Southern Orthopeadic Sports
Columbia, South Carolina, 29204
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Med Investigations, Inc.
Fair Oaks, California, 95628
Clinical Physiology Associates Clinical Study
Fort Meyers, Florida, 33916
DFW Wellness
Fort Worth, Texas, 76108
Houston Sleep Clinic
Houston, Texas, 77063
Professional clinical Research - Interlochen
Interlochen, Michigan, 49643
Commonwealth Biomedical Resaerch, LLC
Madisonville, Kentucky, 42431
Central Pennsylvania Clinic
Mechanicsburg, Pennsylvania, 17055
Northridge Neurological Center
Northridge, California, 91325
Quality Clinical Research, Inc
Omaha, Nebraska, 68114
Compass Research
Orlando, Florida, 32806
Dba 21st Century Neurology
Phoenix, Arizona, 85004
Arizona Research Center
Phoenix, Arizona, 85023
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449
Pacific Rheumatology Associates
Renton, Washington, 98055
The Carolina Center for Rheumatology & ArthiritisCare PA
Rock Hill, South Carolina, 29732
Northern California Research
Sacramento, California, 95821
Superior Research, LLC
Sacramento, California, 95825
Sun Research Institute
San Antonio, Texas, 78215
Apex Research Institute
Santa Ana, California, 92705
Memorial Medical Group - Clinical Research
South Bend, Indiana, 46601
Clinical Health Research, LLC
Sugar Land, Texas, 77479
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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
Being tested: Sodium Oxybate, Sodium Oxybate & 6 Tablets, Sodium Oxybate & 8 Tablets, Sodium Oxybate Oral Solution (6 grams)
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00803023
Study group	Role	What they receive
1	Experimental	Sodium Oxybate Oral Solution (4.5 grams) Receives: Drug: Sodium Oxybate
2	Experimental	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) Receives: Drug: Sodium Oxybate & 6 Tablets
3	Experimental	Sodium Oxybate Oral Solution (6 grams) Receives: Drug: Sodium Oxybate Oral Solution (6 grams)
4	Experimental	Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams) Receives: Drug: Sodium Oxybate & 8 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Measured: 4 weeks

Secondary outcomes (1)

Tolerability Assessed by Adverse Events
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jul 2010

First posted5 Dec 2008 (estimated)
Study startMar 2010
Primary completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00803023
Sponsor's protocol ID: 08-004
Status last verified: Aug 2011
First submitted: 3 Dec 2008
Last updated: 19 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00803023
Acronym / sponsor ID: 08-004
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jul 2010 (actual)
First posted: 5 Dec 2008 (estimated)
Results: Posted 16 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Sodium OxybateSodium Oxybate Oral Solution (4.5 grams)
2	Experimental	Drug: Sodium Oxybate & 6 TabletsSodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
3	Experimental	Drug: Sodium Oxybate Oral Solution (6 grams)Sodium Oxybate Oral Solution (6 grams)
4	Experimental	Drug: Sodium Oxybate & 8 TabletsSodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is able to understand the written informed consent
Subject is 18 years of age or older.
Subject meets the ACR criteria for fibromyalgia
Subject is willing to discontinue prohibited by the protocol
Subject agrees to use only non-sedating over-the-counter (OTC)medication

Key exclusion criteria (14 listed)

Subject has protocol prohibited medical \& psychiatric conditions that would exclude subject
Subject has a current or past history of a substance use disorder including alcohol abuse
Subject has a clinically significant history of seizure disorder either past or present
Female subject who is pregnant, nursing or lactating.
Subject is diagnosed with sleep apnea

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium Oxybate4.5 grams per night taken in two equally divided doses	Drug	1
Sodium Oxybate & 6 Tablets4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night	Drug	2
Sodium Oxybate & 8 Tablets6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night	Drug	4
Sodium Oxybate Oral Solution (6 grams)6 grams per night taken in two equally divided doses	Drug	3

Primary outcome

Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Time frame: 4 weeks

1 secondary outcome

Tolerability Assessed by Adverse Events
Time frame: 4 weeks

Results and safety

Results posted to the registry on 16 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4.5g SXB	32	27
4.5g SXB + 6 Tablets	33	25
6g SXB	31	20
6g SXB + 8 Tablets	33	25

Primary outcome: Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects

Time frame: 4 weeks. Number. Unit: participants

Measure	4.5g SXB n = 32	4.5g SXB + 6 Tablets n = 33	6g SXB n = 31	6g SXB + 8 Tablets n = 33
Any Adverse Event	20	21	21	23
Gastrointestinal Disorders	7	6	5	11
Diarrhea	0	0	1	2
Nausea	4	3	2	7
Vomiting	0	1	1	2
General Disorders & Administration Site Conditions	2	4	5	6
Fatigue	1	0	0	3
Edema Peripheral	1	2	1	1

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4.5g SXB	1 of 32 (3.1%)	12 of 32 (37.5%)	Not reported
4.5g SXB + 6 Tablets	0 of 33 (0%)	13 of 33 (39.4%)	Not reported
6g SXB	1 of 31 (3.2%)	11 of 31 (35.5%)	Not reported
6g SXB + 8 Tablets	0 of 33 (0%)	17 of 33 (51.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grace Wang, MD study director

Jazz Pharmaceuticals

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Oxybate, Sodium Oxybate & 6 Tablets and Sodium Oxybate & 8 Tablets in people with Fibromyalgia, run by Jazz Pharmaceuticals at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.