A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

December 11, 2019 updated by: Pfizer

A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 636 00
        • Pfizer Investigational Site
      • Ceske Budejovice, Czechia, 370 87
        • Pfizer Investigational Site
      • Ostrava, Czechia, 702 00
        • Pfizer Investigational Site
      • Zlin, Czechia, 760 01
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00290
        • Pfizer Investigational Site
      • Kokkola, Finland, 67100
        • Pfizer Investigational Site
      • Lahti, Finland, 15110
        • Pfizer Investigational Site
      • Lohja, Finland, 08200
        • Pfizer Investigational Site
  • Netherlands
      • Almere, Netherlands, 1311 RL
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • Pfizer Investigational Site
      • Venlo, Netherlands, 5912 BL
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7130
        • Pfizer Investigational Site
    • Cape Town
      • Worcester, Cape Town, South Africa, 6850
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Pfizer Investigational Site
    • Gauteng
      • Ennerdale, Gauteng, South Africa, 1820
        • Pfizer Investigational Site
      • Tshwane, Gauteng, South Africa, 0204
        • Pfizer Investigational Site
    • Kwa- Zulu Natal
      • Stanger, Kwa- Zulu Natal, South Africa, 4450
        • Pfizer Investigational Site
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4000
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Pontevedra, Spain, 36071
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35235
        • Pfizer Investigational Site
    • California
      • Mission Viejo, California, United States, 92691
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Pfizer Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Tampa, Florida, United States, 33609
        • Pfizer Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
    • Missouri
      • Marionville, Missouri, United States, 65705
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • New Jersey
      • Elizabeth, New Jersey, United States, 07207
        • Pfizer Investigational Site
      • Hamilton, New Jersey, United States, 08690
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14209
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10024
        • Pfizer Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Pfizer Investigational Site
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77706
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77079
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77081
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of any race at least 18 years of age
  • Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
  • Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

  • Patients with significant hepatic impairment
  • Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
  • Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
  • Amputations other than toes
  • A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
  • History of transient ischemic attack or stroke
  • Myocardial infarction or unstable angina within the past three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral tablet once a day dosing for 10 weeks.
Experimental: 2
Drug: [S,S]-Reboxetine
Oral tablet once a day dosing for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in weekly average pain score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)
Time Frame: 8 weeks
8 weeks
Change from baseline in weekly average sleep interference scale
Time Frame: 8 weeks
8 weeks
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Time Frame: 8 weeks
8 weeks
Modified Brief Pain Inventory-Short Form
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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