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

Primary Purpose

Diabetic Neuropathies

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
[S,S]-Reboxetine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in weekly average pain score

Secondary Outcome Measures

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)
Change from baseline in weekly average sleep interference scale
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory-Short Form

Full Information

First Posted
February 14, 2008
Last Updated
December 11, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00625833
Brief Title
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Official Title
A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated for futility following the planned interim analysis.
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet once a day dosing for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
[S,S]-Reboxetine
Intervention Description
Oral tablet once a day dosing for 10 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in weekly average pain score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline in weekly average sleep interference scale
Time Frame
8 weeks
Title
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Time Frame
8 weeks
Title
Modified Brief Pain Inventory-Short Form
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Pfizer Investigational Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Pfizer Investigational Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Pfizer Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Pfizer Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Pfizer Investigational Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Pfizer Investigational Site
City
Marionville
State/Province
Missouri
ZIP/Postal Code
65705
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Pfizer Investigational Site
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07207
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
Pfizer Investigational Site
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Pfizer Investigational Site
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Pfizer Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Pfizer Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8858
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lohja
ZIP/Postal Code
08200
Country
Finland
Facility Name
Pfizer Investigational Site
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Worcester
State/Province
Cape Town
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Ennerdale
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Tshwane
State/Province
Gauteng
ZIP/Postal Code
0204
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Stanger
State/Province
Kwa- Zulu Natal
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4000
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Pfizer Investigational Site
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061037&StudyName=A%20Trial%20Of%20%5BS%2CS%5D-Reboxetine%20In%20Patients%20With%20Chronic%20Painful%20Diabetic%20Peripheral%20Neuropathy.
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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