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

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Desipramine Desipramine hydrochloride Nortriptyline Methadone Nortriptyline hydrochloride Methadone hydrochloride

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00004390 History of Changes
Other Study ID Numbers:	199/12133, JHUSM-93010802
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:

Herpes Zoster
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Desipramine
Nortriptyline
Methadone

Morphine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 12, 2012