Back to resultsMaintenance of Efficacy.
Primary Purpose
Fibromyalgia
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esreboxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring double-blind placebo-controlled maintenance of efficacy
Eligibility Criteria
Inclusion Criteria:
- Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
- Pain score greater than or equal to 4 on an 11-point NRS
- FIQ-Total score greater than or equal to 45 points
Exclusion Criteria:
- Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
- Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
- Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Esreboxetine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
Change from baseline to 3 and 6 months in the FIQ-Total score
Secondary Outcome Measures
Pain (including other measures of daily pain and responder analyses);
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Global efficacy measures PGIC);
Sleep (MOS);
Work productivity;
Depression (HADS)
Safety (vital signs, ECG, laboratory, suicidal ideation)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00796601
Brief Title
Maintenance of Efficacy.
Official Title
A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
May 1, 2010 (Anticipated)
Study Completion Date
November 1, 2010 (Anticipated)
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
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
double-blind placebo-controlled maintenance of efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esreboxetine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esreboxetine
Intervention Description
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film coated tablets (0 mg esreboxetine), once daily for 6 months
Primary Outcome Measure Information:
Title
Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
Time Frame
6 months
Title
Change from baseline to 3 and 6 months in the FIQ-Total score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain (including other measures of daily pain and responder analyses);
Time Frame
6 months
Title
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Time Frame
6 months
Title
Global efficacy measures PGIC);
Time Frame
6 months
Title
Sleep (MOS);
Time Frame
6 months
Title
Work productivity;
Time Frame
6 months
Title
Depression (HADS)
Time Frame
6 months
Title
Safety (vital signs, ECG, laboratory, suicidal ideation)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
Pain score greater than or equal to 4 on an 11-point NRS
FIQ-Total score greater than or equal to 45 points
Exclusion Criteria:
Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061054&StudyName=Maintenance%20of%20efficacy.
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Maintenance of Efficacy.
We'll reach out to this number within 24 hrs