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| 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 |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 1995 |
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 |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| 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 |
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 |
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