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

NCT00288652 | Completed Phase 2

• 1 other identifier: A6061026
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 79

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - 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

Interventions

[S,S]-Reboxetine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (79)

Pfizer Investigational Site

Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Arcadia, California, United States

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Fullerton, California, United States

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Irvine, California, United States

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Laguna Hills, California, United States

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Loma Linda, California, United States

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Orange, California, United States

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Redondo Beach, California, United States

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Whittier, California, United States

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Boulder, Colorado, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Holly Hill, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Largo, Florida, United States

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Longwood, Florida, United States

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Melbourne, Florida, United States

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Ocala, Florida, United States

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Oviedo, Florida, United States

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Palm Beach Gardens, Florida, United States

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Plantation, Florida, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Evansville, Indiana, United States

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Topeka, Kansas, United States

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Ruston, Louisiana, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Southaven, Mississippi, United States

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Independence, Missouri, United States

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Kansas City, Missouri, United States

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Nixa, Missouri, United States

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Sprinfield, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Clifton, New Jersey, United States

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Hackensack, New Jersey, United States

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Teaneck, New Jersey, United States

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Sante Fe, New Mexico, United States

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Albany, New York, United States

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Amherst, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Canfield, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: March 1, 2006
• Study Completion: February 1, 2007
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (79)