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

Primary Purpose

Pain

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

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

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

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Open Treatment

Standard Care

Arm Description

[S,S]-reboxetine

Standard Care

Outcomes

Primary Outcome Measures

Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events

Secondary Outcome Measures

Pain Visual Analogue Scale
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory-Short Form
Patient Global Impression of Change
SF-12 Health Survey
EQ-5D
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization

Full Information

First Posted
July 4, 2006
Last Updated
May 31, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00348894
Brief Title
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
Official Title
A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Treatment
Arm Type
Experimental
Arm Description
[S,S]-reboxetine
Arm Title
Standard Care
Arm Type
Other
Arm Description
Standard Care
Intervention Type
Drug
Intervention Name(s)
[S,S]-Reboxetine
Intervention Description
[S,S]-reboxetine
Intervention Type
Drug
Intervention Name(s)
Any
Intervention Description
Any standard of care treatment for DPN
Primary Outcome Measure Information:
Title
Vital signs
Time Frame
duration of study
Title
Physical examination
Time Frame
duration of study
Title
12-lead ECG
Time Frame
duration of study
Title
Hematology/Biochemistry
Time Frame
duration of study
Title
Adverse events
Time Frame
duration of study
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale
Time Frame
duration of study
Title
Neuropathic Pain Symptom Inventory
Time Frame
duration of study
Title
Modified Brief Pain Inventory-Short Form
Time Frame
duration of study
Title
Patient Global Impression of Change
Time Frame
duration of study
Title
SF-12 Health Survey
Time Frame
duration of study
Title
EQ-5D
Time Frame
duration of study
Title
Analgesic Treatment Satisfaction Scale
Time Frame
duration of study
Title
Pain-related Medication Utilization
Time Frame
duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Pfizer Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Pfizer Investigational Site
City
Auburn
State/Province
California
ZIP/Postal Code
95602
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Pfizer Investigational Site
City
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Pfizer Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Pfizer Investigational Site
City
Honululu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Pfizer Investigational Site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Pfizer Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Pfizer Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
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
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1034ACO
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1405CWB
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Pärnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Viljandi mk.
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00150
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Seinajoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Pfizer Investigational Site
City
Meissen
ZIP/Postal Code
01662
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Pfizer Investigational Site
City
St.Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tann i.d. Rhoen
ZIP/Postal Code
36142
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuerzburg
ZIP/Postal Code
97072
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 033
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Pfizer Investigational Site
City
Maharashtra
State/Province
Mumbai
ZIP/Postal Code
400 007
Country
India
Facility Name
Pfizer Investigational Site
City
Ansari Nagar
State/Province
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
ZIP/Postal Code
141 001
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
ZIP/Postal Code
632 004
Country
India
Facility Name
Pfizer Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lask
ZIP/Postal Code
98-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-536
Country
Poland
Facility Name
Pfizer Investigational Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng Province
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Gauteng Province
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4000
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Overport
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Houghton, Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Soweto
ZIP/Postal Code
6201
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
40014
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
417 17
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Umea
ZIP/Postal Code
S-901 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49600
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
84003
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061031&StudyName=%5BS%2CS%5D-Reboxetine%20Long%20Term%20Safety%20Study%20In%20Chronic%20Painful%20Diabetic%20Peripheral%20Neuropathy.%0A
Description
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[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

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