[S,S]-Reboxetine Dose-Range Finding Trial
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288652
First received: February 7, 2006
Last updated: June 7, 2011
Last verified: June 2011
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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
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
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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 | |
| United States, Arkansas | |
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| Hot Springs, Arkansas, United States | |
| United States, California | |
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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 | |
| United States, Colorado | |
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| Boulder, Colorado, United States | |
| United States, Florida | |
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| Bradenton, Florida, United States | |
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| Clearwater, Florida, United States | |
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| Ft. Myers, 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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| Oak Brook, Illinois, 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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| 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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| Nixa, Missouri, United States | |
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| Sprinfield, Missouri, United States | |
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| St. Louis, Missouri, United States | |
| United States, Montana | |
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| Billings, Montana, United States | |
| United States, New Jersey | |
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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 | |
| United States, New Mexico | |
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| Sante Fe, New Mexico, United States | |
| United States, New York | |
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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 | |
| United States, North Carolina | |
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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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| Cincinnati, Ohio, United States | |
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| Kettering, Ohio, United States | |
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| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
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| Allentown, Pennsylvania, United States | |
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| Altoona, Pennsylvania, United States | |
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| Duncansville, Pennsylvania, United States | |
| United States, Tennessee | |
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| Jackson, Tennessee, United States | |
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| Kingsport, Tennessee, United States | |
| United States, Texas | |
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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 | |
| United States, Virginia | |
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| Norfolk, Virginia, United States | |
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| Richmond, Virginia, United States | |
| United States, Washington | |
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| Seattle, Washington, United States | |
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| Spokane, Washington, United States | |
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| 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