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[S,S]-Reboxetine Add-On Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334685
Recruitment Status : Terminated (The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).)
First Posted : June 8, 2006
Last Update Posted : December 16, 2019
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 + Pregabalin Drug: Pregabalin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Actual Study Start Date : August 22, 2006
Actual Primary Completion Date : October 4, 2007
Actual Study Completion Date : October 11, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: [S,S]-Reboxetine + Pregabalin Drug: [S,S]-Reboxetine + Pregabalin
[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks

Active Comparator: Pregabalin Drug: Pregabalin
Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks




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 [ Time Frame: Week 10 ]

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


Information from the National Library of Medicine

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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


Locations
Show 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 Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00334685    
Other Study ID Numbers: A6061021
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Pregabalin
Reboxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents