A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00612170
First received: January 29, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.


Condition Intervention Phase
Fibromyalgia
Drug: [S,S]-Reboxetine
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 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the endpoint mean sleep interference score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Fatigue [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Short Form 36 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Pain Visual Analogue Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 1129
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
Sham Comparator: 4 Drug: Placebo
0 mg oral tablet once a day dosing
Experimental: 1 Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
Experimental: 2 Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any race, at least 18 years of age
  • Patients must meet the ACR criteria for fibromyalgia (ie, 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 (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
  • A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
  • History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
  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: NCT00612170

  Show 146 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00612170     History of Changes
Other Study ID Numbers: A6061043, A6061043
Study First Received: January 29, 2008
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014