PainPhase 2NCT00334685
[S,S]-Reboxetine Add-On Trial
A Phase 2 study testing [S,S]-Reboxetine + Pregabalin and Pregabalin in people with Pain, run by Pfizer at 83 sites in 16 countries.
Trial summary
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN 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 + Pregabalin and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 83 sitesin 16 countries
- Study dates
- 22 Aug 2006to 11 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 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
83 sites in 16 countries.
83 sites in 16 countries
Canada16 sites
Pfizer Investigational Site
Calgary, Alberta, T3C 3P1
Pfizer Investigational Site
Calgary, Alberta, T3E 0C5
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Greater Sudbury, Ontario, K3E 3L6
Pfizer Investigational Site
Greater Sudbury, Ontario, P3E 1H5
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
North Bay, Ontario, P1B 2H3
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Québec, Quebec, G1V 4X7
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X1
Pfizer Investigational Site
Saint Romuald, Quebec, G6W 5M6
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
Sasktatoon, Saskatchewan, S7K 6Y6
Pfizer Investigational Site
Val Caron, Ontario, P3N 1G3
Ukraine11 sites
Pfizer Investigational Site
Dnipropetrovsk, 49616
Pfizer Investigational Site
Donetsk, 83045
Pfizer Investigational Site
Kharkiv, 310057
Pfizer Investigational Site
Kharkiv, 61018
Pfizer Investigational Site
Kharkiv, 61068
Pfizer Investigational Site
Kharkiv, 61178
Pfizer Investigational Site
Kyiv, 01021
Pfizer Investigational Site
Kyiv, 04112
Pfizer Investigational Site
Odesa, 65025
Pfizer Investigational Site
Simferopol, 95006
Pfizer Investigational Site
Uzhhorod, 88011
Germany10 sites
Pfizer Investigational Site
Erbach im Odenwald, 64711
Pfizer Investigational Site
Hattingen, 45525
Pfizer Investigational Site
Jena, 07743
Pfizer Investigational Site
Karlsruhe, 76199
Pfizer Investigational Site
Katzhütte, 98746
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
Mainz, 55116
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Münster, 48129
Pfizer Investigational Site
Wiesbaden, 65189
United Kingdom8 sites
Pfizer Investigational Site
Birmingham, West Midlands, B29 6JD
Pfizer Investigational Site
Glasgow, G42 9YU
Pfizer Investigational Site
London, UK, SE13 6LH
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
Manchester, M8 5RB
Pfizer Investigational Site
Plymouth, PL6 8DH
Pfizer Investigational Site
Portsmouth, Hampshire, PO3 6AD
Pfizer Investigational Site
York, YO31 8HE
United States7 sites
Pfizer Investigational Site
Amherst, New York, 14226
Pfizer Investigational Site
Gilbert, Arizona, 85234
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Orchard Park, New York, 14127
Pfizer Investigational Site
St Louis, Missouri, 63141
Spain6 sites
Pfizer Investigational Site
Cadiz, 11009
Pfizer Investigational Site
Granada, 18014
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, 28006
Pfizer Investigational Site
Seville, 41013
Pfizer Investigational Site
Valencia, 46014
Sweden6 sites
Pfizer Investigational Site
Eksjö, 575 81
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Gothenburg, 416 85
Pfizer Investigational Site
Karlstad, 651 85
Pfizer Investigational Site
Skellefteå, 931 86
Pfizer Investigational Site
Stockholm, 114 54
Norway5 sites
Pfizer Investigational Site
Bekkestua, 1319
Pfizer Investigational Site
Lierskogen, N-3421
Pfizer Investigational Site
Oslo, 0027
Pfizer Investigational Site
Sandnes, 4313
Pfizer Investigational Site
Trondheim, 7031
Italy3 sites
Pfizer Investigational Site
Milan, 20127
Pfizer Investigational Site
Naples, 80138
Pfizer Investigational Site
Perugia, 06123
Czechia2 sites
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Pilsen, 304 60
Netherlands2 sites
Pfizer Investigational Site
Breda, 4819 EV
Pfizer Investigational Site
Utrecht, 3584 CX
Poland2 sites
Pfizer Investigational Site
Krakow, 31-531
Pfizer Investigational Site
Poznan, 61-289
Russia2 sites
Pfizer Investigational Site
Saint Petersburg, 194044
Pfizer Investigational Site
Yaroslavl, 150030
About this study
Official title: [S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN
- Conditions
- Pain
- Being tested
- [S,S]-Reboxetine + Pregabalin, Pregabalin
- 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]-Reboxetine + PregabalinDrug
[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
PregabalinDrug
Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| [S,S]-Reboxetine + Pregabalin | Experimental | Not described Receives: Drug: [S,S]-Reboxetine + Pregabalin |
| Pregabalin | Active comparator | Not described Receives: Drug: Pregabalin |
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 10 will be calculated
Measured: Week 10
Secondary outcomes (4)
The mean endpoint (week 10) sleep interference score change from baseline
Measured: Week 10
Analysis of the Medical Outcomes Study Sleep Scale
Measured: Week 10
Analysis of the Patient Global Impression of Change
Measured: Week 10
Analysis of the Neuropathic Pain Symptom Inventory
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study start22 Aug 2006
- Primary completion4 Oct 2007
- Study completion11 Oct 2007
Why it stopped: The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).
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
- Who is masked
- Participant, Investigator
- Enrolment
- 136 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
- NCT00334685
- Sponsor's protocol ID
- A6061021
- Status last verified
- Dec 2019
- First submitted
- 7 Jun 2006
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
- ClinicalTrials.gov ID
- NCT00334685
- Acronym / sponsor ID
- A6061021
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).
- Enrolment
- 136 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2006 (actual)
- Primary completion
- 4 Oct 2007 (actual)
- Study completion
- 11 Oct 2007 (actual)
- First posted
- 8 Jun 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 adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [S,S]-Reboxetine + Pregabalin | Experimental | Drug: [S,S]-Reboxetine + Pregabalin |
| Pregabalin | Active comparator | Drug: Pregabalin |
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 + Pregabalin[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks | Drug | [S,S]-Reboxetine + Pregabalin |
| PregabalinPregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks | Drug | Pregabalin |
Primary outcome
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated
Time frame: Week 10
4 secondary outcomes
The mean endpoint (week 10) sleep interference score change from baseline
Time frame: Week 10
Analysis of the Medical Outcomes Study Sleep Scale
Time frame: Week 10
Analysis of the Patient Global Impression of Change
Time frame: Week 10
Analysis of the Neuropathic Pain Symptom Inventory
Time frame: Week 10
Results and safety
The study was stopped early (reason given: The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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
83 sites in 16 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 + Pregabalin and Pregabalin in people with Pain, run by Pfizer at 83 sites in 16 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 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: stopped early, as of the sponsor's last update on 16 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 83 sites in Canada, Ukraine, Germany, United Kingdom, United States and 11 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 Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).). 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?
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated (time frame: Week 10). 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 16 Dec 2019.