Maintenance of Efficacy.

This study has been withdrawn prior to enrollment.
(This study has been cancelled as the esreboxetine development program is being discontinued. Safety and efficacy were not factors.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00796601
First received: November 20, 2008
Last updated: March 17, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: Esreboxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain (including other measures of daily pain and responder analyses); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Global efficacy measures PGIC); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Sleep (MOS); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Work productivity; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depression (HADS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety (vital signs, ECG, laboratory, suicidal ideation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: May 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796601

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00796601     History of Changes
Other Study ID Numbers: A6061054, A6061054
Study First Received: November 20, 2008
Last Updated: March 17, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014