Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia - Full Text View

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 III

MedlinePlus related topics:

Shingles

Drug Information available for:

Methadone Methadone hydrochloride Desipramine Desipramine hydrochloride Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

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

Study ID Numbers:	199/12133, JHUSM-93010802
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004390
Health Authority:	United States: Federal Government

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

Study placed in the following topic categories:

Herpes Zoster

Neuralgia, Postherpetic

Morphine

Neuralgia

Rare Diseases

Pain

Desipramine

Herpesviridae Infections

Virus Diseases

Signs and Symptoms

Methadone

Neuromuscular Diseases

Peripheral Nervous System Diseases

Nortriptyline

Neurologic Manifestations

DNA Virus Infections

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Physiological Effects of Drugs

Nervous System Diseases

Psychotropic Drugs

Central Nervous System Depressants

Narcotics

Enzyme Inhibitors

Pharmacologic Actions

Antidepressive Agents, Tricyclic

Sensory System Agents

Therapeutic Uses

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Analgesics, Opioid

Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) National Institute of Neurological Disorders and Stroke (NINDS) Johns Hopkins University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004390