FibromyalgiaPhase 3DolastronNCT00820326
Efficacy of Dolasetron in Patients With Fibromyalgia
A Phase 3 study testing Dolasetron in people with Fibromyalgia, run by University Hospital, Limoges at 1 site in France.
Trial summary
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization. This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dolasetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2004to Jun 2008
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75
- Primitive Fibromyalgia according to ACR criteria
- Patient no responding to conventional treatment
- Women of childbearing age using an efficace contraception
- Signed consent
Who cannot join
- Inflammatory rheumatic diseases
- Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
- Infectious diseases: hepatitis B and C, lyme disease, HIV,
- Hypothyroidism,
- Bone and mineral metabolism disorders
- Disorders of cardiac conduction
Show all 11Show fewer
- Failure of Heart, of kidney or liver,
- Patient allergic to dolasetron
- Pregnant or nursing women
- Women without means of contraception,
- Age <18 or > 75 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.
This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).
Read more
Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.
This treatment will be renewed after one month, after 2 months and after 3 months.
If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.
Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.
- Conditions
- Fibromyalgia
- Being tested
- Dolasetron, Placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolasetronDrug
Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
PlaceboDrug
Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
| Study group | Role | What they receive |
|---|---|---|
| Dolasetron | Active comparator | Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 Receives: Drug: Dolasetron |
| Placebo | Placebo comparator | Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
Measured: Inclusion visit and month 3
Secondary outcomes (4)
Improving visual analogue scale (VAS)
Measured: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale
Measured: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Anxiety index
Measured: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Number of painful trigger points
Measured: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMar 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820326
- Sponsor's protocol ID
- I03002
- Acronym
- Dolastron
- Status last verified
- Jan 2009
- First submitted
- 27 Dec 2008
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Vergne-Salle P, Dufauret-Lombard C, Bonnet C, Simon A, Treves R, Bonnabau H, Bertin P. A randomised, double-blind, placebo-controlled trial of dolasetron, a 5-hydroxytryptamine 3 receptor antagonist, in patients with fibromyalgia. Eur J Pain. 2011 May;15(5):509-14. doi: 10.1016/j.ejpain.2010.09.013. Epub 2010 Oct 30.
PubMed 21036635
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00820326
- Acronym / sponsor ID
- Dolastron / I03002
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Jan 2009 (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.
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.
This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).
Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.
This treatment will be renewed after one month, after 2 months and after 3 months.
If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.
Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dolasetron | Active comparator | Drug: DolasetronPatients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo everyday for 4 days at J0, M1, M2 and M3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 75
- Primitive Fibromyalgia according to ACR criteria
- Patient no responding to conventional treatment
- Women of childbearing age using an efficace contraception
- Signed consent
Key exclusion criteria (11 listed)
- Inflammatory rheumatic diseases
- Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
- Infectious diseases: hepatitis B and C, lyme disease, HIV,
- Hypothyroidism,
- Bone and mineral metabolism disorders
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 |
|---|---|---|
| DolasetronPatients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 | Drug | Dolasetron |
| PlaceboPatients will receive placebo everyday for 4 days at J0, M1, M2 and M3 | Drug | Placebo |
Primary outcome
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
Time frame: Inclusion visit and month 3
4 secondary outcomes
Improving visual analogue scale (VAS)
Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale
Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Anxiety index
Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Number of painful trigger points
Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
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 16 Jul 2025.
- Results publication: PubMed 21036635Vergne-Salle P, Dufauret-Lombard C, Bonnet C, Simon A, Treves R, Bonnabau H, Bertin P. A randomised, double-blind, placebo-controlled trial of dolasetron, a 5-hydroxytryptamine 3 receptor antagonist, in patients with fibromyalgia. Eur J Pain. 2011 May;15(5):509-14. doi: 10.1016/j.ejpain.2010.09.013. Epub 2010 Oct 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolasetron in people with Fibromyalgia, run by University Hospital, Limoges at 1 site in France.
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 5 inclusion and 11 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 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?
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?
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3 (time frame: Inclusion visit and month 3). 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 NCT00820326, which also lists 1 linked publication.
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 16 Jul 2025.