[S,S]-Reboxetine Add-On Trial

NCT ID: NCT00334685

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-22

Study Completion Date

2007-10-11

Brief Summary

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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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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[S,S]-Reboxetine + Pregabalin

Group Type EXPERIMENTAL

[S,S]-Reboxetine + Pregabalin

Intervention Type DRUG

\[S,S\]-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

Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks

Interventions

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[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

Intervention Type DRUG

Pregabalin

Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Huntsville, Alabama, United States

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Gilbert, Arizona, United States

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North Dartmouth, Massachusetts, United States

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St Louis, Missouri, United States

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Amherst, New York, United States

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Orchard Park, New York, United States

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Kettering, Ohio, United States

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Vienna, , Austria

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Langley, British Columbia, Canada

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Greater Sudbury, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hawkesbury, Ontario, Canada

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North Bay, Ontario, Canada

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Val Caron, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Sasktatoon, Saskatchewan, Canada

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České Budějovice, , Czechia

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Pilsen, , Czechia

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Erbach im Odenwald, , Germany

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Hattingen, , Germany

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Jena, , Germany

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Karlsruhe, , Germany

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Katzhütte, , Germany

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Mainz, , Germany

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Mainz, , Germany

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München, , Germany

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Münster, , Germany

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Wiesbaden, , Germany

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Milan, , Italy

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Napoli, , Italy

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Perugia, , Italy

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Riga, , Latvia

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Breda, , Netherlands

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Utrecht, , Netherlands

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Bekkestua, , Norway

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Lierskogen, , Norway

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Oslo, , Norway

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Sandnes, , Norway

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Trondheim, , Norway

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Krakow, , Poland

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Poznan, , Poland

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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L'Hospitalet de Llobregat, Barcelona, Spain

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Cadiz, , Spain

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Granada, , Spain

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Madrid, , Spain

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Seville, , Spain

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Valencia, , Spain

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Eksjö, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Karlstad, , Sweden

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Skellefteå, , Sweden

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Stockholm, , Sweden

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Zurich, , Switzerland

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Uzhhorod, , Ukraine

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Portsmouth, Hampshire, United Kingdom

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London, UK, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Plymouth, , United Kingdom

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York, , United Kingdom

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Countries

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United States Austria Canada Czechia Germany Italy Latvia Netherlands Norway Poland Russia Spain Sweden Switzerland Ukraine United Kingdom

Related Links

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Other Identifiers

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A6061021

Identifier Type: -

Identifier Source: org_study_id