FibromyalgiaPhase 3NCT00796601
Maintenance of Efficacy.
A Phase 3 study testing Esreboxetine in people with Fibromyalgia, run by Pfizer.
Trial summary
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Esreboxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2009to 1 Nov 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
- Pain score greater than or equal to 4 on an 11-point NRS
- FIQ-Total score greater than or equal to 45 points
Who cannot join
- Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
- Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
- Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
About this study
Official title: A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
- Conditions
- Fibromyalgia
- Being tested
- Esreboxetine, Placebo
- Keywords
- double-blind placebo-controlled maintenance of efficacy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsreboxetineDrug
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
PlaceboDrug
Film coated tablets (0 mg esreboxetine), once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Esreboxetine | Experimental | Not described Receives: Drug: Esreboxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
Measured: 6 months
Change from baseline to 3 and 6 months in the FIQ-Total score
Measured: 6 months
Secondary outcomes (7)
Pain (including other measures of daily pain and responder analyses);
Measured: 6 months
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Measured: 6 months
Global efficacy measures PGIC);
Measured: 6 months
Sleep (MOS);
Measured: 6 months
Work productivity;
Measured: 6 months
Depression (HADS)
Measured: 6 months
Safety (vital signs, ECG, laboratory, suicidal ideation)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study start1 May 2009
- Primary completion1 May 2010 (estimated)
- Study completion1 Nov 2010 (estimated)
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.
- More trials run by PfizerThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796601
- Sponsor's protocol ID
- A6061054
- Other IDs
- A6061054, 2008-006760-10, 2008
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2008
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00796601
- Acronym / sponsor ID
- A6061054
- Conditions
- Fibromyalgia
- Keywords
- double-blind placebo-controlled maintenance of efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2009 (actual)
- Primary completion
- 1 May 2010 (estimated)
- Study completion
- 1 Nov 2010 (estimated)
- First posted
- 24 Nov 2008 (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.
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esreboxetine | Experimental | Drug: Esreboxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
- Pain score greater than or equal to 4 on an 11-point NRS
- FIQ-Total score greater than or equal to 45 points
Key exclusion criteria (3 listed)
- Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
- Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
- Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
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 |
|---|---|---|
| EsreboxetineFilm coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months | Drug | Esreboxetine |
| PlaceboFilm coated tablets (0 mg esreboxetine), once daily for 6 months | Drug | Placebo |
Primary outcome
Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
Time frame: 6 months
Change from baseline to 3 and 6 months in the FIQ-Total score
Time frame: 6 months
7 secondary outcomes
Pain (including other measures of daily pain and responder analyses);
Time frame: 6 months
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Time frame: 6 months
Global efficacy measures PGIC);
Time frame: 6 months
Sleep (MOS);
Time frame: 6 months
Work productivity;
Time frame: 6 months
Depression (HADS)
Time frame: 6 months
Safety (vital signs, ECG, laboratory, suicidal ideation)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esreboxetine in people with Fibromyalgia, run by Pfizer.
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 3 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: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). (time frame: 6 months). The study lists 2 primary outcomes in all. 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 29 Nov 2018.