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[S,S]-Reboxetine Add-On Trial

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ClinicalTrials.gov Identifier: NCT00334685
Recruitment Status : Terminated (The DMC terminated the study on the basis of futility (insufficient clinical response).)
First Posted : June 8, 2006
Last Update Posted : July 17, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN

Condition or disease Intervention/treatment Phase
Pain Drug: [S,S]-Reboxetine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: [S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
Study Start Date : July 2006



Primary Outcome Measures :
  1. The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated

Secondary Outcome Measures :
  1. The mean endpoint (week 10) sleep interference score change from baseline
  2. Analysis of the Medical Outcomes Study Sleep Scale
  3. Analysis of the Patient Global Impression of Change
  4. Analysis of the Neuropathic Pain Symptom Inventory


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334685


  Show 83 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00334685     History of Changes
Other Study ID Numbers: A6061021
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: July 17, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
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Reboxetine
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs