PainPhase 2NCT00354094
[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
A Phase 2 study testing [S,S]-Reboxetine in people with Pain, run by Pfizer at 40 sites in 12 countries.
Trial summary
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles. 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
- 600 participants
- Where
- 40 sitesin 12 countries
- Study dates
- Nov 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 pain present for more than 3 months after healing of the shingles skin rash.
- Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
Who cannot join
- Patients with significant hepatic impairment.
- Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).
Trial locations and contacts
40 sites in 12 countries.
40 sites in 12 countries
India7 sites
Pfizer Investigational Site
Bangalore, 560 034
Pfizer Investigational Site
Chandigarh, Punjab, 160 012
Pfizer Investigational Site
Chennai, 600 116
Pfizer Investigational Site
Hyderabad, Andhra Pradhesh, 500 033
Pfizer Investigational Site
Hyderabad, 500 033
Pfizer Investigational Site
New Delhi, 110 002
Pfizer Investigational Site
New Delhi, 110 076
United Kingdom7 sites
Pfizer Investigational Site
Addlestone, SURREY, KT15 2BH
Pfizer Investigational Site
Alcester, B49 5DZ
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ
Pfizer Investigational Site
East Sussex, TN40 3RJ
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
London, SW18 4DD
Pfizer Investigational Site
London, WC1X 8LD
United States6 sites
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Fargo, North Dakota, 58104
Pfizer Investigational Site
Greensboro, North Carolina, 27401
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Canada5 sites
Pfizer Investigational Site
Greater Sudbury, Ontario, P3A 1Y4
Pfizer Investigational Site
Greater Sudbury, Ontario, P3A 1Y8
Pfizer Investigational Site
Greater Sudbury, Ontario, P3E 1H5
Pfizer Investigational Site
Montreal, Quebec, H3S 2W1
Pfizer Investigational Site
Toronto, Ontario, M3M 3E5
Argentina4 sites
Pfizer Investigational Site
Buenos Aires, Buenos Aires, C1280AEB
Pfizer Investigational Site
Buenos Aires, C1015ABR
Pfizer Investigational Site
Buenos Aires, C1133AAW
Pfizer Investigational Site
Buenos Aires, C1428AQK
Lithuania4 sites
Pfizer Investigational Site
Kaunas, 50009
Pfizer Investigational Site
Klaipėda, 92304
Pfizer Investigational Site
Panevezys, 35144
Pfizer Investigational Site
Šiauliai, 76231
Chile2 sites
Pfizer Investigational Site
Santiago, RM
Pfizer Investigational Site
Viña del Mar, Valparaiso, 2520021
About this study
Official title: A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.
- 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.
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
Secondary outcomes (8)
Pain Visual Analogue Scale
Patient Global Impression of Change
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory - Short Form
SF-12 Health Survey
EQ-5D
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startNov 2006
- Study completionOct 2007
Why it stopped: The study was stopped due to business/operational issues.
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
- None (open label)
- Enrolment
- 600 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
- NCT00354094
- Sponsor's protocol ID
- A6061030
- Status last verified
- Nov 2007
- First submitted
- 18 Jul 2006
- Last updated
- 8 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).
- ClinicalTrials.gov ID
- NCT00354094
- Acronym / sponsor ID
- A6061030
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to business/operational issues.
- Enrolment
- 600 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 20 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 (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 healing of the shingles skin rash.
- Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
Key exclusion criteria (2 listed)
- Patients with significant hepatic impairment.
- Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).
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
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
8 secondary outcomes
Pain Visual Analogue Scale
Patient Global Impression of Change
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory - Short Form
SF-12 Health Survey
EQ-5D
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization
Results and safety
The study was stopped early (reason given: The study was stopped due to business/operational issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2007.
- 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
40 sites in 12 countries: 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 40 sites in 12 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 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 8 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in India, United Kingdom, United States, Canada, Argentina and 7 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 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: The study was stopped due to business/operational issues.). 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 8 Nov 2007.