FibromyalgiaPhase 2NCT00087555
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
A Phase 2 study testing Xyrem (sodium oxybate) oral solution in people with Fibromyalgia, run by Jazz Pharmaceuticals at 20 sites in United States.
Trial summary
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Xyrem (sodium oxybate) oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2004to Jan 2006
- Phase
- Phase 2
- 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
- Sign \& date informed consent
- Willing \& able to complete trial as described in protocol
- > 18 years of age
- Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right \& left sides of body; (2) Pain above \& below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites]
- (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4.
- Discontinue all prescription medication taken for fibromyalgia, including opiates, benzodiazepines, anticonvulsants taken for pain, antidepressants, cyclobenzaprine (Flexeril), and/or tramadol (Ultram) until study completion
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- Continue all pre-existing nutritional and/or exercise regimens and/or behavioral, massage, acupuncture, physical or cognitive therapies on an unchanged, consistent \& regular schedule throughout study
- Use only acetaminophen or over-the-counter non-steroidal anti-inflammatory drugs as rescue pain medications \& to limit dose to the labeled over-the-counter maximum. Aspirin may only be used as a cardiac protectant; formulations with caffeine are excluded.
- Forego ingestion of alcohol for duration of study.
- Fertile females must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) for duration of trial.
Who cannot join
- Have any of the following medical conditions:
- Other rheumatic disease, such as rheumatoid arthritis, osteoarthritis, or systemic lupus erythematosis
- Uncontrolled hypo- or hyper-thyroidism of any type
- Unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place patient at risk during trial or compromise objectives outlined in protocol
- Myocardial infarction within last six months
- On their screening PSG (polysomnogram) have an Apnea Index greater than 10 per hour or an Apnea Hypopnea Index greater than 15 per hour. Note: patients with sleep apnea are not excluded if their indices are below these thresholds while sleeping with CPAP (Continuous Positive Airway Pressure) and they are compliant with CPAP therapy.
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- Problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
- If a patient will have to discontinue antidepressant medication taken for depression, the investigator must make an evaluation as to any risks from cessation of anti-depressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant patient harm exists, patient is excluded from study participation
- Current or recent history of substance abuse including alcohol abuse
- History of seizure disorder, history of head trauma, migraine headaches or intracranial surgery, \& are taking anticonvulsants
- Succinic semialdehyde dehydrogenase deficiency
- Have taken any of these therapies:
- gamma-hydroxybutyrate (sodium oxybate) in 30 days prior to signing informed consent
- any investigational therapy in 30 days prior to signing informed consent
- ever taken anticonvulsants to treat epilepsy or any other convulsions
- Unwilling to stop these therapies during course of trial:
- anticonvulsants prescribed solely for pain
- all antidepressants
- medication for sleep
- Have any of the following clinical laboratory results:
- Serum creatinine > 2.0 mg/dL
- TSH (Thyroid Stimulating Hormone) < 0.3 μU/mL OR TSH > 6 μU/mL
- abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal)
- elevated serum bilirubin (more than 1.5 times the upper limit of normal)
- pre-trial ECG with arrhythmia, greater than a first degree AV block
- positive pregnancy test at any time during trial
- Have any of the following socio-economic factors:
- Pending worker's compensation litigation or related other monetary settlements
- Have an occupation that requires variable shift work or routine night shifts
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Osteoporosis Medical Center
Beverly Hills, California, 90211
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Duke University Medical Center
Durham, North Carolina, 27710
Abigail Rebecca Neiman, MD
Katy, Texas, 77450
Alvin Daughtridge Arthritis Center
Lenoir, North Carolina, 28645
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Miami Research Associates
Miami, Florida, 33173
Cleveland Sleep Center
Middlebrook Heights, Ohio, 44130
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Oregon Health and Science University
Portland, Oregon, 97239
C.A.R.E. Center
Raleigh, North Carolina, 27609
Pacific Rheumatology Research, Inc.
Renton, Washington, 98055
The University of Texas Health Science Center
San Antonio, Texas, 78229
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital
Sandy City, Utah, 84094
Radiant Research
Scottsdale, Arizona, 85251
Seattle Rheumatology Associates
Seattle, Washington, 98104
LSU Health Sciences Center
Shreveport, Louisiana, 71130-3932
Richard N. Podell, MD
Springfield, New Jersey, 07081
Radiant Research, Inc.
West Palm Beach, Florida, 33407
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Read the detailed description
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.
- Conditions
- Fibromyalgia
- Being tested
- Xyrem (sodium oxybate) oral solution, Placebo
- Keywords
- Fibromyalgia, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xyrem (sodium oxybate) oral solutionDrug
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
Xyrem (sodium oxybate) oral solutionDrug
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
PlaceboDrug
Placebo one of two doses matching active treatment by volume for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Sodium oxybate 6.0 g per day. Receives: Drug: Xyrem (sodium oxybate) oral solution |
| 3 | Placebo comparator | Placebo (one of two doses matching active treatment by volume). Receives: Drug: Placebo |
| 1 | Experimental | Sodium oxybate 4.5 g per day. Receives: Drug: Xyrem (sodium oxybate) oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).
The percentage of participants who met all 3 of the following criteria:
Reduction of >=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionApr 2005
- Study completionJan 2006
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.
- Publications (6)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yanping Zheng, MD, Study director, Jazz Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087555
- Sponsor's protocol ID
- OMC-SXB-26
- Status last verified
- Jan 2012
- First submitted
- 12 Jul 2004
- Last updated
- 24 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
PubMed 11833860A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
PubMed 12627729U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004 Mar;5(2):119-23. doi: 10.1016/j.sleep.2003.11.002.
PubMed 15033130The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms. J Toxicol Clin Toxicol. 2003;41(2):131-5. doi: 10.1081/clt-120019128.
PubMed 12733850Scharf MB, Baumann M, Berkowitz DV. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol. 2003 May;30(5):1070-4.
PubMed 12734908Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.
PubMed 19116896
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00087555
- Acronym / sponsor ID
- OMC-SXB-26
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Jul 2004 (estimated)
- Results
- Posted 10 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Detailed description
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Xyrem (sodium oxybate) oral solutionSodium oxybate 6.0 g per day. |
| 3 | Placebo comparator | Drug: PlaceboPlacebo (one of two doses matching active treatment by volume). |
| 1 | Experimental | Drug: Xyrem (sodium oxybate) oral solutionSodium oxybate 4.5 g per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign \& date informed consent
- Willing \& able to complete trial as described in protocol
- > 18 years of age
- Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right \& left sides of body; (2) Pain above \& below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites]
- (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4.
Key exclusion criteria (29 listed)
- Have any of the following medical conditions:
- Have taken any of these therapies:
- Unwilling to stop these therapies during course of trial:
- Have any of the following clinical laboratory results:
- Have any of the following socio-economic factors:
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 |
|---|---|---|
| Xyrem (sodium oxybate) oral solutionXyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks. | Drug | 1 |
| Xyrem (sodium oxybate) oral solutionXyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks. | Drug | 2 |
| PlaceboPlacebo one of two doses matching active treatment by volume for 8 weeks. | Drug | 3 |
Primary outcome
The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).
Time frame: Baseline to week 8
The percentage of participants who met all 3 of the following criteria: Reduction of >=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11833860A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
- Background: PubMed 12627729A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
- Background: PubMed 15033130U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004 Mar;5(2):119-23. doi: 10.1016/j.sleep.2003.11.002.
- Background: PubMed 12733850The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms. J Toxicol Clin Toxicol. 2003;41(2):131-5. doi: 10.1081/clt-120019128.
- Background: PubMed 12734908Scharf MB, Baumann M, Berkowitz DV. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol. 2003 May;30(5):1070-4.
- Background: PubMed 19116896Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.
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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.
Yanping Zheng, MD study director
Jazz Pharmaceuticals, Inc
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xyrem (sodium oxybate) oral solution in people with Fibromyalgia, run by Jazz Pharmaceuticals at 20 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 10 inclusion and 29 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 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Jan 2012). 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?
The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C). (time frame: Baseline to week 8). 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 NCT00087555, which also lists 6 linked publications.
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 24 Jan 2012.