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[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

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: NCT00354094
Recruitment Status : Terminated (The study was stopped due to business/operational issues.)
First Posted : July 20, 2006
Last Update Posted : November 8, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).
Study Start Date : November 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles




Primary Outcome Measures :
  1. Vital signs
  2. Physical examination
  3. 12-lead ECG
  4. Hematology/Biochemistry
  5. Adverse events

Secondary Outcome Measures :
  1. Pain Visual Analogue Scale
  2. Patient Global Impression of Change
  3. Neuropathic Pain Symptom Inventory
  4. Modified Brief Pain Inventory - Short Form
  5. SF-12 Health Survey
  6. EQ-5D
  7. Analgesic Treatment Satisfaction Scale
  8. Pain-related Medication Utilization


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 healing of the shingles skin rash.
  • Patients at screening must have a score of >/=40mm on the pain visual analogue scale.

Exclusion Criteria:

  • Patients with significant hepatic impairment.
  • Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

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): NCT00354094


Locations
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United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33606
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, North Carolina
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27401
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104
United States, Rhode Island
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78213
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1015ABR
Pfizer Investigational Site
Buenos Aires, Argentina, C1133AAW
Pfizer Investigational Site
Buenos Aires, Argentina, C1280AEB
Pfizer Investigational Site
Buenos Aires, Argentina, C1428AQK
Canada, Ontario
Pfizer Investigational Site
Sudbury, Ontario, Canada, P3A 1Y4
Pfizer Investigational Site
Sudbury, Ontario, Canada, P3A 1Y8
Pfizer Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
Pfizer Investigational Site
Toronto, Ontario, Canada, M3M 3E5
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3S 2W1
Chile
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Viña del Mar, V Región, Chile, 2520021
Croatia
Pfizer Investigational Site
Split, Croatia, 21000
India
Pfizer Investigational Site
Hyderabad, Andhra Pradhesh, India, 500 033
Pfizer Investigational Site
Chandigarh, Punjab, India, 160 012
Pfizer Investigational Site
Bangalore, India, 560 034
Pfizer Investigational Site
Chennai, India, 600 116
Pfizer Investigational Site
Hyderabad, India, 500 033
Pfizer Investigational Site
New Delhi, India, 110 002
Pfizer Investigational Site
New Delhi, India, 110 076
Lithuania
Pfizer Investigational Site
Kaunas, Lithuania, 50009
Pfizer Investigational Site
Klaipeda, Lithuania, 92304
Pfizer Investigational Site
Panevezys, Lithuania, 35144
Pfizer Investigational Site
Siauliai, Lithuania, 76231
Mexico
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
Poland
Pfizer Investigational Site
Sopot, Poland, 81-855
Spain
Pfizer Investigational Site
Ourense, Spain, 32005
Sweden
Pfizer Investigational Site
Stockholm, Sweden, S-141 86
United Kingdom
Pfizer Investigational Site
Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
Pfizer Investigational Site
Addlestone, Surrey, United Kingdom, KT15 2BH
Pfizer Investigational Site
Alcester, United Kingdom, B49 5DZ
Pfizer Investigational Site
East Sussex, United Kingdom, TN40 3RJ
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
Pfizer Investigational Site
London, United Kingdom, SW18 4DD
Pfizer Investigational Site
London, United Kingdom, WC1X 8LD
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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ClinicalTrials.gov Identifier: NCT00354094    
Other Study ID Numbers: A6061030
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: November 2007
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