FibromyalgiaPhase 3NCT00607256
Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia
A Phase 3 study testing [S,S]-reboxetine in people with Fibromyalgia, run by Pfizer at 79 sites in 11 countries.
Trial summary
To evaluate the lon-term safety and tolerability 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
- Fibromyalgia
- What is being tested?
- [S,S]-reboxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 79 sitesin 11 countries
- Study dates
- 20 Oct 2007to 18 May 2009
- 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
- Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
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
Trial locations and contacts
79 sites in 11 countries.
79 sites in 11 countries
United States39 sites
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Charleston, South Carolina, 29412
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cranston, Rhode Island, 02920
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Denver, Colorado, 80239
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77063
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Kenilworth, New Jersey, 07033
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Marion, Ohio, 43302
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Moline, Illinois, 61265
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Orangevale, California, 95662
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Germany8 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 14109
Pfizer Investigational Site
Eichstätt, 85072
Pfizer Investigational Site
Göppingen, 73033
Pfizer Investigational Site
Hamburg, 20095
Pfizer Investigational Site
Mannheim, 68161
Pfizer Investigational Site
München, 80336
Pfizer Investigational Site
Wiesbaden, 65189
United Kingdom6 sites
Pfizer Investigational Site
Cambridge, CB2 0QQ
Pfizer Investigational Site
Colchester, C04 5JL
Pfizer Investigational Site
Derby, DE1 2QY
Pfizer Investigational Site
Dudley, West Midlands, DY1 2HQ
Pfizer Investigational Site
Greenock, PA16 0XN
Pfizer Investigational Site
Paisley, PA2 7DE
Canada4 sites
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Moncton, New Brunswick, E1G 1A7
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Czechia4 sites
Pfizer Investigational Site
Hlučín, 748 01
Pfizer Investigational Site
Pardubice, 530 02
Pfizer Investigational Site
Prague, 128 50
Pfizer Investigational Site
Zlín, 760 01
South Africa4 sites
Pfizer Investigational Site
Boksburg, Gauteng, 1462
Pfizer Investigational Site
Panorama, Western Cape, 7500
Pfizer Investigational Site
Parow, Western Cape, 7500
Pfizer Investigational Site
Pretoria, Gauteng, 0001
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 412 55
Pfizer Investigational Site
Mölndal, 431 37
Pfizer Investigational Site
Stockholm, 115 22
Pfizer Investigational Site
Stockholm, 182 88
France3 sites
Pfizer Investigational Site
Lille, Cedex, 59037
Pfizer Investigational Site
Nice, 06002
Pfizer Investigational Site
Paris, 75181
Netherlands3 sites
Pfizer Investigational Site
Breda, 4819 EV
Pfizer Investigational Site
Emmen, 7824 AA
Pfizer Investigational Site
Leeuwarden, 8934 AD
Belgium2 sites
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Pellenberg, 3212
South Korea2 sites
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Suwon, Kyeongki-do, 442-712
About this study
Official title: A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
- Conditions
- Fibromyalgia
- Being tested
- [S,S]-reboxetine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[S,S]-reboxetineDrug
S_S reboxetine dosed daily.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Not described Receives: Drug: [S,S]-reboxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-lead ECG
Measured: 68 weeks
Hematology/Biochemistry
Measured: 68 weeks
Adverse events
Measured: 68 weeks
Physical examination
Measured: 68 weeks
Vital signs
Measured: 68 weeks
Secondary outcomes (1)
Patient Global Impression of Change
Measured: 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study start20 Oct 2007
- Primary completion18 May 2009
- Study completion18 May 2009
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT00607256
- Sponsor's protocol ID
- A6061046
- Status last verified
- Dec 2019
- First submitted
- 23 Jan 2008
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00607256
- Acronym / sponsor ID
- A6061046
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2007 (actual)
- Primary completion
- 18 May 2009 (actual)
- Study completion
- 18 May 2009 (actual)
- First posted
- 5 Feb 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.
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: [S,S]-reboxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
Key exclusion criteria (1 listed)
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
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]-reboxetineS_S reboxetine dosed daily. | Drug | Open Label |
Primary outcome
12-lead ECG
Time frame: 68 weeks
Hematology/Biochemistry
Time frame: 68 weeks
Adverse events
Time frame: 68 weeks
Physical examination
Time frame: 68 weeks
Vital signs
Time frame: 68 weeks
1 secondary outcome
Patient Global Impression of Change
Time frame: 68 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- 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
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [S,S]-reboxetine in people with Fibromyalgia, run by Pfizer at 79 sites in 11 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Germany, United Kingdom, Canada, Czechia and 6 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 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 stopped early. Results are not available in the source record.
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?
12-lead ECG (time frame: 68 weeks). The study lists 5 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 13 Dec 2019.