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Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
[S,S]-reboxetine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

  • Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Global Impression of Change

Full Information

First Posted
January 23, 2008
Last Updated
December 11, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00607256
Brief Title
Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia
Official Title
A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Study Start Date
October 20, 2007 (Actual)
Primary Completion Date
May 18, 2009 (Actual)
Study Completion Date
May 18, 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[S,S]-reboxetine
Intervention Description
S_S reboxetine dosed daily.
Primary Outcome Measure Information:
Title
12-lead ECG
Time Frame
68 weeks
Title
Hematology/Biochemistry
Time Frame
68 weeks
Title
Adverse events
Time Frame
68 weeks
Title
Physical examination
Time Frame
68 weeks
Title
Vital signs
Time Frame
68 weeks
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change
Time Frame
68 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Exclusion Criteria: Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
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
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Pfizer Investigational Site
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Pfizer Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Pfizer Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Pfizer Investigational Site
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Pfizer Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
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
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Pfizer Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Pfizer Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
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
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Nice Cedex 1
ZIP/Postal Code
06002
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Eichstaett
ZIP/Postal Code
85072
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goeppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Pfizer Investigational Site
City
Suwon-si
State/Province
Kyeongki-do
ZIP/Postal Code
442-712
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Emmen
ZIP/Postal Code
7824 AA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Pretoria
State/Province
Gauteng Province
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1462
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
412 55
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
ZIP/Postal Code
431 37
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Colchester
ZIP/Postal Code
C04 5JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Derby
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dudley, West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenock
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Paisley
ZIP/Postal Code
PA2 7DE
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061046&StudyName=Long-term%20OL%20study%20of%20%5BS%2CS%5D-RBX%20in%20patients%20with%20fibromyalgia
Description
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Learn more about this trial

Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

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