FibromyalgiaPhase 2NCT00377039
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
A Phase 2 study testing AD 337 in people with Fibromyalgia, run by Sosei at 1 site in United Kingdom.
Trial summary
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- AD 337
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2006to Aug 2007
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18-65
- Meet ACR 1990 criteria for classification of Fibromyalgia
- Able and willing to discontinue CNS active therapies
Who cannot join
- If pain is NOT primarily due to Fibromyalgia
- Current or prior history of serious psychiatric disorder
- Pregnant/breastfeeding
- QTc > 470ms
- Failure to respond to 2 or more adequate regimes of different classes of antidepressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.
- Conditions
- Fibromyalgia
- Being tested
- AD 337
- Keywords
- ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD 337Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Secondary outcomes (7)
These will be
FIQ Total score at weeks 1, 2, 3, at end of study and overall
FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sosei
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David L Scott, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377039
- Sponsor's protocol ID
- AD337-021
- Status last verified
- Sep 2007
- First submitted
- 14 Sep 2006
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.
- ClinicalTrials.gov ID
- NCT00377039
- Acronym / sponsor ID
- AD337-021
- Conditions
- Fibromyalgia
- Keywords
- ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SoseiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Sep 2006 (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 is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Age 18-65
- Meet ACR 1990 criteria for classification of Fibromyalgia
- Able and willing to discontinue CNS active therapies
Key exclusion criteria (5 listed)
- If pain is NOT primarily due to Fibromyalgia
- Current or prior history of serious psychiatric disorder
- Pregnant/breastfeeding
- QTc > 470ms
- Failure to respond to 2 or more adequate regimes of different classes of antidepressants.
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 |
|---|---|---|
| AD 337 | Drug | – |
Primary outcome
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
7 secondary outcomes
These will be
FIQ Total score at weeks 1, 2, 3, at end of study and overall
FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
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 2 Oct 2007.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
David L Scott principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD 337 in people with Fibromyalgia, run by Sosei at 1 site in United Kingdom.
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 4 inclusion and 5 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 2 Oct 2007. 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 United Kingdom. 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?
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment. 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 2 Oct 2007.