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Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004390
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Johns Hopkins University
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of pain than treatment with tricyclic antidepressant (nortriptyline).

II. Assess the effects the two treatments have on affective and cognitive functions.

III. Determine whether the presence of psychiatric comorbidity, particularly depression, can predict the outcome of the two treatments.


Condition Intervention Phase
Pain Herpes Zoster Drug: desipramine Drug: methadone Drug: morphine Drug: nortriptyline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 120
Study Start Date: February 1995
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are stratified by the duration of pain (greater than 1 year or no greater than 1 year) and the presence or absence of major depression.

Patients are randomized into 6 treatment order groups. Patients start with nortriptyline, morphine, or placebo, taken orally every day. If patients are unable to tolerate nortriptyline or morphine, they will receive desipramine or methadone instead.

A drug titration period lasting 3 weeks is ensued for administration of the first drug treatment. The goal of this titration period is to gradually increase the dose of the drug to obtain maximal analgesic efficacy. Drug dosage is maintained for a period of 3 weeks. The drug dosage is tapered off and followed by a drug free period of 1 week.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnostically confirmed postherpetic neuralgia for at least 3 months following a segmental herpes zoster eruption

--Prior/Concurrent Therapy--

  • Other: No concurrent monoamine oxidase inhibitors

--Patient Characteristics--

  • Life expectancy: At least 6 months
  • Cardiovascular: No second degree or complete heart blockage No myocardial infarction in the last 3 months
  • Pulmonary: No severe pulmonary disease
  • Other: No history of substance abuse No history of dementia No history of encephalopathy No severe depression that precludes withdrawal from antidepressants Not pregnant No angle-closure glaucoma No AIDS related disease complex No terminal disease with life expectancy of less that 6 months
  Contacts and Locations
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): NCT00004390


Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS)
Johns Hopkins University
Investigators
Study Chair: Srinivasa N. Raja Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00004390     History of Changes
Other Study ID Numbers: 199/12133
JHUSM-93010802
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
Last Verified: February 2000

Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition
herpes zoster infection
herpesvirus infection
immunologic disorders and infectious disorders
pain
rare disease
viral infection

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morphine
Methadone
Nortriptyline
Desipramine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Enzyme Inhibitors