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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00354094

Purpose

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	Intervention	Phase
Pain	Drug: [S,S]-Reboxetine	Phase II

MedlinePlus related topics: Shingles

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events

Secondary Outcome Measures:

Pain Visual Analogue Scale
Patient Global Impression of Change
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory - Short Form
SF-12 Health Survey
EQ-5D
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization

Estimated Enrollment:	600
Study Start Date:	November 2006
Study Completion Date:	October 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 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354094

Show 40 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A6061030
Study First Received:	July 18, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00354094
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuralgia, Postherpetic
Herpes Zoster
Neuralgia
Pain
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009