Maintenance of Efficacy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796601
Recruitment Status : Withdrawn (This study has been cancelled as the esreboxetine development program is being discontinued. Safety and efficacy were not factors.)
First Posted : November 24, 2008
Last Update Posted : March 18, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Esreboxetine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Esreboxetine Drug: Esreboxetine
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
Placebo Comparator: Placebo Drug: Placebo
Film coated tablets (0 mg esreboxetine), once daily for 6 months

Primary Outcome Measures :
  1. 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 ]
  2. Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pain (including other measures of daily pain and responder analyses); [ Time Frame: 6 months ]
  2. Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); [ Time Frame: 6 months ]
  3. Global efficacy measures PGIC); [ Time Frame: 6 months ]
  4. Sleep (MOS); [ Time Frame: 6 months ]
  5. Work productivity; [ Time Frame: 6 months ]
  6. Depression (HADS) [ Time Frame: 6 months ]
  7. Safety (vital signs, ECG, laboratory, suicidal ideation) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796601

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00796601     History of Changes
Other Study ID Numbers: A6061054
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by Pfizer:
double-blind placebo-controlled maintenance of efficacy

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases