[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

NCT ID: NCT00348894

Last Updated: 2011-06-01

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

2006-07-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to assess the long-term safety and tolerability of \[S,S\]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy

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

NONE

Study Groups

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Open Treatment

\[S,S\]-reboxetine

Group Type EXPERIMENTAL

[S,S]-Reboxetine

Intervention Type DRUG

\[S,S\]-reboxetine

Standard Care

Standard Care

Group Type OTHER

Any

Intervention Type DRUG

Any standard of care treatment for DPN

Interventions

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[S,S]-Reboxetine

\[S,S\]-reboxetine

Intervention Type DRUG

Any

Any standard of care treatment for DPN

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
* Patients at screening must have a score \>/=40 mm on the pain visual analogue scale

Exclusion Criteria

* Patients with significant hepatic impairment
* Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
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

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Jonesboro, Arkansas, United States

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Auburn, California, United States

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Huntington Beach, California, United States

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Orangevale, California, United States

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Naples, Florida, United States

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Winter Park, Florida, United States

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Honululu, Hawaii, United States

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Chicago, Illinois, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Nashua, New Hampshire, United States

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Syracuse, New York, United States

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Greensboro, North Carolina, United States

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Dallas, Texas, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Osijek, , Croatia

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Split, , Croatia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Tartu, , Estonia

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Viljandi Mk., , Estonia

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Helsinki, , Finland

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Oulu, , Finland

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Seinäjoki, , Finland

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Tampere, , Finland

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Bad Mergentheim, , Germany

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Mainz, , Germany

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Meissen, , Germany

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Münster, , Germany

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St.Ingbert, , Germany

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Tann I.d. Rhoen, , Germany

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Würzburg, , Germany

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Maharashtra, Mumbai, India

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Ansārinagar, New Delhi, India

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Ludhiana, , India

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Vellore, , India

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Bytom, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Otwock, , Poland

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Wroclaw, , Poland

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Łask, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Johannesburg, Gauteng, South Africa

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Parktown, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, Overport, South Africa

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Durban, , South Africa

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Durban, , South Africa

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Houghton, Johannesburg, , South Africa

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Pretoria, , South Africa

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Soweto, , South Africa

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Carshalton, Surrey, United Kingdom

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Bath, , United Kingdom

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Dundee, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Argentina Canada Croatia Estonia Finland Germany India Poland Russia South Africa Sweden Ukraine United Kingdom

Related Links

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Other Identifiers

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A6061031

Identifier Type: -

Identifier Source: org_study_id

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