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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

desipramine

methadone

morphine

nortriptyline

About this trial

This is an interventional treatment trial for Pain focused on measuring disease-related problem/condition, herpes zoster infection, herpesvirus infection, immunologic disorders and infectious disorders, pain, rare disease, viral infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004390

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT00004390

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2000

Overall Recruitment Status

Completed

Study Start Date

February 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), Johns Hopkins University

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Herpes Zoster

Keywords

disease-related problem/condition, herpes zoster infection, herpesvirus infection, immunologic disorders and infectious disorders, pain, rare disease, viral infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

desipramine

Intervention Type

Drug

Intervention Name(s)

methadone

Intervention Type

Drug

Intervention Name(s)

morphine

Intervention Type

Drug

Intervention Name(s)

nortriptyline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Srinivasa N. Raja

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

Pain, Herpes Zoster

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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