PainPhase 2NCT00353808
A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.
A Phase 2 study testing [S,S]-Reboxetine in people with Pain, run by Pfizer at 57 sites in United States.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 57 sitesUnited States
- Study dates
- Jul 2006to Oct 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 met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
- Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
Who cannot join
- Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
- Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Amherst, New York, 14226
Pfizer Investigational Site
Ann Arbor, Michigan, 48104
Pfizer Investigational Site
Arcadia, California, 91007
Pfizer Investigational Site
Asheville, North Carolina, 28806
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Boulder, Colorado, 80304
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Canfield, Ohio, 44406
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Clearwater, Florida, 33765
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635-0909
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Gilbert, Arizona, 85234
Pfizer Investigational Site
Holly Hill, Florida, 32117
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77063
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Independence, Missouri, 64055
Pfizer Investigational Site
Irvine, California, 92618
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Laguna Hills, California, 92653
Pfizer Investigational Site
Largo, Florida, 33770
Pfizer Investigational Site
Loma Linda, California, 92354
Pfizer Investigational Site
Longwood, Florida, 32779
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Nixa, Missouri, 65714
Pfizer Investigational Site
Oak Brook, Illinois, 60523
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Orchard Park, New York, 14127
Pfizer Investigational Site
Ormond Beach, Florida, 32174
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33418
Pfizer Investigational Site
Raleigh, North Carolina, 27607-6520
Pfizer Investigational Site
Redondo Beach, California, 90277
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Ruston, Louisiana, 71270
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Sun City, Arizona, 85351
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Towson, Maryland, 21286
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Youngstown, Ohio, 44504
About this study
Official title: An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.
- 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
| Study group | Role | What they receive |
|---|---|---|
| s, s reboxetine | 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.
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
Secondary outcomes (2)
Pain Visual Analogue Scale
Patient Global Impression of Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJul 2006
- Study completionOct 2007
Why it stopped: This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
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
- NCT00353808
- Sponsor's protocol ID
- A6061029
- Status last verified
- Apr 2011
- First submitted
- 17 Jul 2006
- Last updated
- 7 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
- ClinicalTrials.gov ID
- NCT00353808
- Acronym / sponsor ID
- A6061029
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 19 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 long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| s, s reboxetine | 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 (2 listed)
- Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
- Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
Key exclusion criteria (2 listed)
- Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
- Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.
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 | s, s reboxetine |
Primary outcome
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
2 secondary outcomes
Pain Visual Analogue Scale
Patient Global Impression of Change
Results and safety
The study was stopped early (reason given: This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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
57 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 57 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: stopped early, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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 was stopped early (reason given: This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.). 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?
Vital signs. 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 7 Apr 2011.