PainPhase 2NCT00357825
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
A Phase 2 study testing [S,S]-Reboxetine in people with Pain, run by Pfizer at 61 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- [S,S]-Reboxetine
- How many people
- 246 participants
- Where
- 61 sitesUnited States
- Study dates
- Aug 2006to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
Who cannot join
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- Patients with severe hepatic impairment.
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Auburn, California, 95602
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Camp Hill, Pennsylvania, 17011
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Charlotte, North Carolina, 28209-3734
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dayton, Ohio, 45402
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635-0909
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Everett, Washington, 98201
Pfizer Investigational Site
Fall River, Massachusetts, 02720
Pfizer Investigational Site
Georgetown, Texas, 78626
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Kansas City, Missouri, 64106
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Mansfield, Massachusetts, 02048
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Moline, Illinois, 61265
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Orangevale, California, 95662
Pfizer Investigational Site
Phoenix, Arizona, 85007
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Pismo Beach, California, 93449
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Wellesley Hills, Massachusetts, 02481-2106
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Worcester, Massachusetts, 01610
About this study
Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
- Conditions
- Pain
- Being tested
- [S,S]-Reboxetine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[S,S]-ReboxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Average Pain Score from the Daily Pain Diary.
Secondary outcomes (12)
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Patient Global Impression of Change
Short-Form 36 Health Survey (SF 36)
Sheehan Disability Scale
Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
Quality of Sleep Score from the Daily Sleep Diary
Multidimensional Assessment of Fatigue (MAF)
Hospital Anxiety and Depression Scales (HADS)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Fibromyalgia Health Assessment Questionnaire (F-HAQ)
Safety and Tolerability
Exposure Response Relationship Between Daily Dose and Daily Pain Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionMar 2007
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 PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 246 participants
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
- NCT00357825
- Sponsor's protocol ID
- A6061034
- Status last verified
- May 2013
- First submitted
- 26 Jul 2006
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Aug;32(9):1618-32. doi: 10.1016/j.clinthera.2010.08.003.
PubMed 20974319
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00357825
- Acronym / sponsor ID
- A6061034
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Jul 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.
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
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 (2 listed)
- At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
Key exclusion criteria (2 listed)
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- Patients with severe hepatic impairment.
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 |
|---|---|---|
| [S,S]-Reboxetine | Drug | – |
Primary outcome
Weekly Average Pain Score from the Daily Pain Diary.
12 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Patient Global Impression of Change
Short-Form 36 Health Survey (SF 36)
Sheehan Disability Scale
Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
Quality of Sleep Score from the Daily Sleep Diary
Multidimensional Assessment of Fatigue (MAF)
Hospital Anxiety and Depression Scales (HADS)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Fibromyalgia Health Assessment Questionnaire (F-HAQ)
Safety and Tolerability
Exposure Response Relationship Between Daily Dose and Daily Pain Score
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 May 2013.
- Derived from this study: PubMed 20974319Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Aug;32(9):1618-32. doi: 10.1016/j.clinthera.2010.08.003.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
61 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 [S,S]-Reboxetine in people with Pain, run by Pfizer at 61 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 2 inclusion and 2 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 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 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. 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?
Weekly Average Pain Score from the Daily Pain Diary.. 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 NCT00357825, 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 15 May 2013.