Study Stopped
The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).
[S,S]-Reboxetine Add-On Trial
1 other identifier
interventional
136
16 countries
83
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Aug 2006
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedStudy Start
First participant enrolled
August 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2007
CompletedDecember 16, 2019
December 1, 2019
1.1 years
June 7, 2006
December 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 10
Secondary Outcomes (4)
The mean endpoint (week 10) sleep interference score change from baseline
Week 10
Analysis of the Medical Outcomes Study Sleep Scale
Week 10
Analysis of the Patient Global Impression of Change
Week 10
Analysis of the Neuropathic Pain Symptom Inventory
Week 10
Study Arms (2)
[S,S]-Reboxetine + Pregabalin
EXPERIMENTALPregabalin
ACTIVE COMPARATORInterventions
\[S,S\]-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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (83)
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Gilbert, Arizona, 85234, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Amherst, New York, 14226, United States
Pfizer Investigational Site
Orchard Park, New York, 14127, United States
Pfizer Investigational Site
Kettering, Ohio, 45429, United States
Pfizer Investigational Site
Vienna, A - 1090, Austria
Pfizer Investigational Site
Calgary, Alberta, T3C 3P1, Canada
Pfizer Investigational Site
Calgary, Alberta, T3E 0C5, Canada
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8, Canada
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4, Canada
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9, Canada
Pfizer Investigational Site
Greater Sudbury, Ontario, K3E 3L6, Canada
Pfizer Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1, Canada
Pfizer Investigational Site
North Bay, Ontario, P1B 2H3, Canada
Pfizer Investigational Site
Val Caron, Ontario, P3N 1G3, Canada
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
Pfizer Investigational Site
Québec, Quebec, G1V 4X7, Canada
Pfizer Investigational Site
Saint Romuald, Quebec, G6W 5M6, Canada
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X1, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9, Canada
Pfizer Investigational Site
Sasktatoon, Saskatchewan, S7K 6Y6, Canada
Pfizer Investigational Site
České Budějovice, 370 87, Czechia
Pfizer Investigational Site
Pilsen, 304 60, Czechia
Pfizer Investigational Site
Erbach im Odenwald, 64711, Germany
Pfizer Investigational Site
Hattingen, 45525, Germany
Pfizer Investigational Site
Jena, 07743, Germany
Pfizer Investigational Site
Karlsruhe, 76199, Germany
Pfizer Investigational Site
Katzhütte, 98746, Germany
Pfizer Investigational Site
Mainz, 55101, Germany
Pfizer Investigational Site
Mainz, 55116, Germany
Pfizer Investigational Site
München, 81675, Germany
Pfizer Investigational Site
Münster, 48129, Germany
Pfizer Investigational Site
Wiesbaden, 65189, Germany
Pfizer Investigational Site
Milan, 20127, Italy
Pfizer Investigational Site
Napoli, 80138, Italy
Pfizer Investigational Site
Perugia, 06123, Italy
Pfizer Investigational Site
Riga, LV 1002, Latvia
Pfizer Investigational Site
Breda, 4819 EV, Netherlands
Pfizer Investigational Site
Utrecht, 3584 CX, Netherlands
Pfizer Investigational Site
Bekkestua, 1319, Norway
Pfizer Investigational Site
Lierskogen, N-3421, Norway
Pfizer Investigational Site
Oslo, 0027, Norway
Pfizer Investigational Site
Sandnes, 4313, Norway
Pfizer Investigational Site
Trondheim, 7031, Norway
Pfizer Investigational Site
Krakow, 31-531, Poland
Pfizer Investigational Site
Poznan, 61-289, Poland
Pfizer Investigational Site
Saint Petersburg, 194044, Russia
Pfizer Investigational Site
Yaroslavl, 150030, Russia
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Pfizer Investigational Site
Cadiz, 11009, Spain
Pfizer Investigational Site
Granada, 18014, Spain
Pfizer Investigational Site
Madrid, 28006, Spain
Pfizer Investigational Site
Seville, 41013, Spain
Pfizer Investigational Site
Valencia, 46014, Spain
Pfizer Investigational Site
Eksjö, 575 81, Sweden
Pfizer Investigational Site
Gothenburg, 413 45, Sweden
Pfizer Investigational Site
Gothenburg, 416 85, Sweden
Pfizer Investigational Site
Karlstad, 651 85, Sweden
Pfizer Investigational Site
Skellefteå, 931 86, Sweden
Pfizer Investigational Site
Stockholm, 114 54, Sweden
Pfizer Investigational Site
Zurich, 8008, Switzerland
Pfizer Investigational Site
Dnipropetrovsk, 49616, Ukraine
Pfizer Investigational Site
Donetsk, 83045, Ukraine
Pfizer Investigational Site
Kharkiv, 310057, Ukraine
Pfizer Investigational Site
Kharkiv, 61018, Ukraine
Pfizer Investigational Site
Kharkiv, 61068, Ukraine
Pfizer Investigational Site
Kharkiv, 61178, Ukraine
Pfizer Investigational Site
Kyiv, 01021, Ukraine
Pfizer Investigational Site
Kyiv, 04112, Ukraine
Pfizer Investigational Site
Odesa, 65025, Ukraine
Pfizer Investigational Site
Simferopol, 95006, Ukraine
Pfizer Investigational Site
Uzhhorod, 88011, Ukraine
Pfizer Investigational Site
Portsmouth, Hampshire, PO3 6AD, United Kingdom
Pfizer Investigational Site
London, UK, SE13 6LH, United Kingdom
Pfizer Investigational Site
Birmingham, West Midlands, B29 6JD, United Kingdom
Pfizer Investigational Site
Glasgow, G42 9YU, United Kingdom
Pfizer Investigational Site
London, EC1A 7BE, United Kingdom
Pfizer Investigational Site
Manchester, M8 5RB, United Kingdom
Pfizer Investigational Site
Plymouth, PL6 8DH, United Kingdom
Pfizer Investigational Site
York, YO31 8HE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2006
First Posted
June 8, 2006
Study Start
August 22, 2006
Primary Completion
October 4, 2007
Study Completion
October 11, 2007
Last Updated
December 16, 2019
Record last verified: 2019-12