Fibromyalgia Syndrome, PrimaryPhase 2NCT00256893
Fibromyalgia Study In Adults
A Phase 2 study testing ropinirole in people with Fibromyalgia Syndrome, Primary, run by GlaxoSmithKline at 22 sites in 9 countries.
Trial summary
A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia Syndrome, Primary
- What is being tested?
- ropinirole
- How many people
- 164 participants
- Where
- 22 sitesin 9 countries
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
- Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
- Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
- Only subjects experiencing moderate/severe pain (pain intensity score >= 4 on the pain numerical rating scale) will be eligible for this study.
- Subjects that are generally well.
- Have the ability to discontinue prohibited medications for the duration of the study.
Who cannot join
- Subjects with 'flare' of arthritic conditions.
- Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
- History of drug and/or alcohol abuse or major depression.
Trial locations and contacts
22 sites in 9 countries.
22 sites in 9 countries
Germany4 sites
GSK Investigational Site
Bad Hersfeld, Hesse, 36251
GSK Investigational Site
Fellbach, Baden-Wurttemberg, 70736
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Hüttenberg, Hesse, 35625
Belgium3 sites
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Diepenbeek, 3590
GSK Investigational Site
Merksem, 2170
Finland3 sites
GSK Investigational Site
Jyväskylä, 40100
GSK Investigational Site
Kuopio, 70100
GSK Investigational Site
Mikkeli, 50100
France3 sites
GSK Investigational Site
Lomme, 59160
GSK Investigational Site
Paris, 75006
GSK Investigational Site
Paris, 75012
Italy3 sites
GSK Investigational Site
Benevento, Campania, 82100
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Rome, Lazio, 00161
United Kingdom3 sites
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
GSK Investigational Site
Poole, Dorset, BH15 2JB
GSK Investigational Site
Truro, Cornwall, TR1 3LJ
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia
A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.
- Conditions
- Fibromyalgia Syndrome, Primary
- Being tested
- ropinirole
- Keywords
- pain intensity, numerical rating scale, fibromyalgia
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity score from baseline to last week of treatment (week 12)
Secondary outcomes (1)
Pain relief. Global function: PGIC (Patient Global Impression of Change)and CGIC (Clinical Global Impression of Change), FIQ (Fibromyalgia Impact Questionnaire), Pain severity and impact on physical function, Sleep quality, tender pointpressure threshold
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startNov 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia Syndrome, PrimaryStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Enrolment
- 164 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256893
- Sponsor's protocol ID
- ROF102100
- Status last verified
- Sep 2016
- First submitted
- 21 Nov 2005
- Last updated
- 15 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00256893
- Acronym / sponsor ID
- ROF102100
- Conditions
- Fibromyalgia Syndrome, Primary
- Keywords
- pain intensity, numerical rating scale, fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
- Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
- Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
- Only subjects experiencing moderate/severe pain (pain intensity score >= 4 on the pain numerical rating scale) will be eligible for this study.
- Subjects that are generally well.
Key exclusion criteria (3 listed)
- Subjects with 'flare' of arthritic conditions.
- Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
- History of drug and/or alcohol abuse or major depression.
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 |
|---|---|---|
| ropinirole | Drug | – |
Primary outcome
Change in pain intensity score from baseline to last week of treatment (week 12)
1 secondary outcome
Pain relief. Global function: PGIC (Patient Global Impression of Change)and CGIC (Clinical Global Impression of Change), FIQ (Fibromyalgia Impact Questionnaire), Pain severity and impact on physical function, Sleep quality, tender pointpressure threshold
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
22 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ropinirole in people with Fibromyalgia Syndrome, Primary, run by GlaxoSmithKline at 22 sites in 9 countries.
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 3 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Belgium, Finland, France, Italy and 4 more countries. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain intensity score from baseline to last week of treatment (week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2016; AzTrials last refreshed its copy on 29 Oct 2026.