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CompletedNCT00004390Updated Jun 24, 2005

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

A Phase 3 interventional study of desipramine and methadone in Pain and Herpes Zoster, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Center for Research Resources (NCRR) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Herpes Zoster

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Keywords

  • disease-related problem/condition
  • herpes zoster infection
  • herpesvirus infection
  • immunologic disorders and infectious disorders
  • pain
  • rare disease
  • viral infection
03

In context

Herpes Zoster

360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.

This study's enrollment of 120 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
120 participants

Interventions

  • Drugdesipramine
  • Drugmethadone
  • Drugmorphine
  • Drugnortriptyline
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004390
Lead sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Johns Hopkins University
First posted
Oct 19, 1999
Start date
Feb 1995
Last update
Jun 24, 2005

Study contacts

Srinivasa N. Raja
study chair · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2000. You cannot join it, but the record below documents what was studied.

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