[S,S]-Reboxetine Dose-Range Finding Trial

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288652
First received: February 7, 2006
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection


Condition Intervention Phase
Pain
Drug: [S,S]-Reboxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: [S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

Secondary Outcome Measures:
  • - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey

Estimated Enrollment: 280
Study Start Date: March 2006
Study Completion Date: February 2007
  Eligibility

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

Inclusion Criteria:

  • Patients must have pain present for more than 3 months after the healing of shingles skin rash
  • Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria:

  • Patients with significant renal and hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
  • Patients with clinically abnormal electrocardiogram
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288652

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Huntsville, Alabama, United States
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Sun City, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States
United States, California
Pfizer Investigational Site
Arcadia, California, United States
Pfizer Investigational Site
Fullerton, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Laguna Hills, California, United States
Pfizer Investigational Site
Loma Linda, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Redondo Beach, California, United States
Pfizer Investigational Site
Whittier, California, United States
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States
United States, Florida
Pfizer Investigational Site
Bradenton, Florida, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Ft. Myers, Florida, United States
Pfizer Investigational Site
Holly Hill, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Kissimmee, Florida, United States
Pfizer Investigational Site
Largo, Florida, United States
Pfizer Investigational Site
Longwood, Florida, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Oviedo, Florida, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States
Pfizer Investigational Site
Plantation, Florida, United States
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Oak Brook, Illinois, United States
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States
United States, Kansas
Pfizer Investigational Site
Topeka, Kansas, United States
United States, Louisiana
Pfizer Investigational Site
Ruston, Louisiana, United States
United States, Maryland
Pfizer Investigational Site
Towson, Maryland, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Brockton, Massachusetts, United States
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
United States, Mississippi
Pfizer Investigational Site
Southaven, Mississippi, United States
United States, Missouri
Pfizer Investigational Site
Independence, Missouri, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Nixa, Missouri, United States
Pfizer Investigational Site
Sprinfield, Missouri, United States
Pfizer Investigational Site
St. Louis, Missouri, United States
United States, Montana
Pfizer Investigational Site
Billings, Montana, United States
United States, New Jersey
Pfizer Investigational Site
Clifton, New Jersey, United States
Pfizer Investigational Site
Hackensack, New Jersey, United States
Pfizer Investigational Site
Teaneck, New Jersey, United States
United States, New Mexico
Pfizer Investigational Site
Sante Fe, New Mexico, United States
United States, New York
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Amherst, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Orchard Park, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
United States, North Carolina
Pfizer Investigational Site
Asheville, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States
United States, Ohio
Pfizer Investigational Site
Canfield, Ohio, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Kettering, Ohio, United States
Pfizer Investigational Site
Toledo, Ohio, United States
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States
Pfizer Investigational Site
Altoona, Pennsylvania, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
United States, Tennessee
Pfizer Investigational Site
Jackson, Tennessee, United States
Pfizer Investigational Site
Kingsport, Tennessee, United States
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Tacoma, Washington, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00288652     History of Changes
Other Study ID Numbers: A6061026
Study First Received: February 7, 2006
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
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 June 17, 2013