Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004390
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHUSM-93010802 | None | None | None |