PainPhase 2NCT00288652
[S,S]-Reboxetine Dose-Range Finding Trial
A Phase 2 study testing [S,S]-Reboxetine in people with Pain, run by Pfizer at 79 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection 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
- 280 participants
- Where
- 79 sitesUnited States
- Study dates
- Mar 2006to Feb 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
- Patients must have pain present for more than 3 months after the healing of shingles skin rash
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Who cannot join
- Patients with significant renal and hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
- Patients with clinically abnormal electrocardiogram
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Allentown, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania
Pfizer Investigational Site
Amherst, New York
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Arcadia, California
Pfizer Investigational Site
Asheville, North Carolina
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Billings, Montana
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Boulder, Colorado
Pfizer Investigational Site
Bradenton, Florida
Pfizer Investigational Site
Brockton, Massachusetts
Pfizer Investigational Site
Canfield, Ohio
Pfizer Investigational Site
Chandler, Arizona
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Clearwater, Florida
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Clifton, New Jersey
Pfizer Investigational Site
Columbus, Ohio
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Duncansville, Pennsylvania
Pfizer Investigational Site
Evansville, Indiana
Pfizer Investigational Site
Fargo, North Dakota
Pfizer Investigational Site
Fort Myers, Florida
Pfizer Investigational Site
Fullerton, California
Pfizer Investigational Site
Hackensack, New Jersey
Pfizer Investigational Site
Holly Hill, Florida
Pfizer Investigational Site
Hollywood, Florida
Pfizer Investigational Site
Hot Springs, Arkansas
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Huntsville, Alabama
Pfizer Investigational Site
Independence, Missouri
Pfizer Investigational Site
Irvine, California
Pfizer Investigational Site
Jackson, Tennessee
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Kettering, Ohio
Pfizer Investigational Site
Kingsport, Tennessee
Pfizer Investigational Site
Kissimmee, Florida
Pfizer Investigational Site
Laguna Hills, California
Pfizer Investigational Site
Largo, Florida
Pfizer Investigational Site
Loma Linda, California
Pfizer Investigational Site
Longwood, Florida
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Mesa, Arizona
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Nixa, Missouri
Pfizer Investigational Site
Norfolk, Virginia
Pfizer Investigational Site
Oak Brook, Illinois
Pfizer Investigational Site
Ocala, Florida
Pfizer Investigational Site
Oklahoma City, Oklahoma
Pfizer Investigational Site
Orange, California
Pfizer Investigational Site
Orchard Park, New York
Pfizer Investigational Site
Oviedo, Florida
Pfizer Investigational Site
Palm Beach Gardens, Florida
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Plantation, Florida
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Redondo Beach, California
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Ruston, Louisiana
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
Sante Fe, New Mexico
Pfizer Investigational Site
Seattle, Washington
Pfizer Investigational Site
Southaven, Mississippi
Pfizer Investigational Site
Spokane, Washington
Pfizer Investigational Site
Sprinfield, Missouri
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Sun City, Arizona
Pfizer Investigational Site
Tacoma, Washington
Pfizer Investigational Site
Teaneck, New Jersey
Pfizer Investigational Site
Toledo, Ohio
Pfizer Investigational Site
Topeka, Kansas
Pfizer Investigational Site
Towson, Maryland
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Whittier, California
Pfizer Investigational Site
Winston-Salem, North Carolina
About this study
Official title: [S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection
- 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.
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
Secondary outcomes (1)
- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 280 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288652
- Sponsor's protocol ID
- A6061026
- Status last verified
- Jun 2011
- First submitted
- 7 Feb 2006
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT00288652
- Acronym / sponsor ID
- A6061026
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 8 Feb 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 determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection
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)
- Patients must have pain present for more than 3 months after the healing of shingles skin rash
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Key exclusion criteria (3 listed)
- Patients with significant renal and hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
- Patients with clinically abnormal electrocardiogram
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
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
1 secondary outcome
- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey
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 8 Jun 2011.
- 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 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 79 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 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: finished, as of the sponsor's last update on 8 Jun 2011. 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. 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 numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated. 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 8 Jun 2011.