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Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia Clinical research trials and Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia. Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia clinical trial. Human subjects often obtain the finest healthcare possible for their Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia  Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
For Condition: Herpes Zoster,Pain
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Neurological Disorders and Stroke (NINDS),Johns Hopkins University
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/90 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
SrinivasaRaja, Study Chair, Johns Hopkins University
Additional Information:
Study ID Numbers: 199/12133; JHUSM-93010802
Study Start Date: February 1995
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004390
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Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
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