Maintenance of Efficacy.

November 27, 2018 updated by: Pfizer

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

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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:

  • 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;

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
Film coated tablets (0 mg esreboxetine), once daily for 6 months
Experimental: Esreboxetine
Drug: Esreboxetine
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months
Change from baseline to 3 and 6 months in the FIQ-Total score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain (including other measures of daily pain and responder analyses);
Time Frame: 6 months
6 months
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Time Frame: 6 months
6 months
Global efficacy measures PGIC);
Time Frame: 6 months
6 months
Sleep (MOS);
Time Frame: 6 months
6 months
Work productivity;
Time Frame: 6 months
6 months
Depression (HADS)
Time Frame: 6 months
6 months
Safety (vital signs, ECG, laboratory, suicidal ideation)
Time Frame: 6 months
6 months

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 (Actual)

May 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061054
  • 2008-006760-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

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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