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

NCT00348894 | Terminated Phase 2

• 1 other identifier: A6061031
• Study Type: interventional
• Target: 136
• Locations: 14 countries
• Sites: 93

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

• Vital signs

  duration of study

• Physical examination

  duration of study

• 12-lead ECG

  duration of study

• Hematology/Biochemistry

  duration of study

• Adverse events

  duration of study

Secondary Outcomes (8)

• Pain Visual Analogue Scale

  duration of study

• Neuropathic Pain Symptom Inventory

  duration of study

• Modified Brief Pain Inventory-Short Form

  duration of study

• Patient Global Impression of Change

  duration of study

• SF-12 Health Survey

  duration of study

Study Arms (2)

Open Treatment

EXPERIMENTAL

\[S,S\]-reboxetine

Drug: [S,S]-Reboxetine

Standard Care

OTHER

Standard Care

Drug: Any

Interventions

[S,S]-Reboxetine DRUG

\[S,S\]-reboxetine

Open Treatment

Any DRUG

Any standard of care treatment for DPN

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (93)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85050, United States

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Scottsdale, Arizona, 85254, United States

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Jonesboro, Arkansas, 72401, United States

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Auburn, California, 95602, United States

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Huntington Beach, California, 92648, United States

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Orangevale, California, 95662, United States

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Naples, Florida, 34102, United States

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Winter Park, Florida, 32789, United States

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Honululu, Hawaii, 96814, United States

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Chicago, Illinois, 60610, United States

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Columbia, Missouri, 65212, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68105, United States

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Las Vegas, Nevada, 89148, United States

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Reno, Nevada, 89509, United States

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Nashua, New Hampshire, 03063, United States

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Syracuse, New York, 13210, United States

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Greensboro, North Carolina, 27408, United States

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Dallas, Texas, 75246, United States

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Richmond, Virginia, 23225, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, C1034ACO, Argentina

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Buenos Aires, C1181ACH, Argentina

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Buenos Aires, C1280AEB, Argentina

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Buenos Aires, C1405CWB, Argentina

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Buenos Aires, C1426ABP, Argentina

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Winnipeg, Manitoba, R3E 3P4, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Osijek, 31000, Croatia

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Split, 21000, Croatia

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Pärnu, 80018, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50406, Estonia

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Tartu, 51014, Estonia

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Viljandi Mk., 71024, Estonia

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Helsinki, 00150, Finland

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Oulu, 90100, Finland

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Seinäjoki, 60220, Finland

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Tampere, 33520, Finland

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Bad Mergentheim, 97980, Germany

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Mainz, 55116, Germany

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Meissen, 01662, Germany

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Münster, 48145, Germany

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St.Ingbert, 66386, Germany

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Tann I.d. Rhoen, 36142, Germany

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Würzburg, 97072, Germany

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Hyderabad, Andhra Pradesh, 500 033, India

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Bangalore, Karnataka, 560 054, India

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Maharashtra, Mumbai, 400 007, India

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Ansārinagar, New Delhi, 110 029, India

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Ludhiana, 141 001, India

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Vellore, 632 004, India

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Bytom, 41-902, Poland

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Lodz, 93-338, Poland

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Lublin, 20-536, Poland

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Otwock, 05-400, Poland

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Wroclaw, 50-088, Poland

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Łask, 98-100, Poland

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Moscow, 119021, Russia

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Moscow, 123423, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Johannesburg, Gauteng, 1827, South Africa

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Parktown, Gauteng, 2193, South Africa

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Durban, KwaZulu-Natal, 4000, South Africa

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Durban, Overport, 4091, South Africa

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Durban, 4001, South Africa

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Durban, 4091, South Africa

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Houghton, Johannesburg, 2198, South Africa

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Pretoria, 0001, South Africa

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Soweto, 6201, South Africa

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Gothenburg, 40014, Sweden

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Gothenburg, 413 45, Sweden

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Gothenburg, 417 17, Sweden

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Stockholm, 115 22, Sweden

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Umeå, S-901 85, Sweden

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Dnipropetrovsk, 49600, Ukraine

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Donetsk, 84003, Ukraine

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Kharkiv, 61070, Ukraine

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Kyiv, 02091, Ukraine

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Odesa, 65009, Ukraine

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Carshalton, Surrey, SM5 1AA, United Kingdom

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Bath, BA1 3NG, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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London, SE5 9RS, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

SE (5); RU (4); IN (6); ZA (9); UA (5); CA (6); GB (5); CR (2); US (24); AR (5); ES (5); DE (7); FI (4); PL (6)