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

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ClinicalTrials.gov Identifier: NCT00004390
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Johns Hopkins University
Information provided by:
Office of Rare Diseases (ORD)

October 18, 1999
October 19, 1999
June 24, 2005
February 1995
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No Changes Posted
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Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
  • Pain
  • Herpes Zoster
  • Drug: desipramine
  • Drug: methadone
  • Drug: morphine
  • Drug: nortriptyline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
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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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004390
199/12133
JHUSM-93010802
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National Center for Research Resources (NCRR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Johns Hopkins University
Study Chair: Srinivasa N. Raja Johns Hopkins University
Office of Rare Diseases (ORD)
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP