Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006427
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2000-11-01
Brief Title:
Chronic Pain After Amputation
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation
Status:
COMPLETED
Status Verified Date:
2011-05
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:
This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
Detailed Description:
This double-masked placebo controlled trial will randomize patients n125 who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks Patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment Study participants will also be interviewed by telephone to assess pain pain interference with activities physical and mental health and number of health care visits for pain at the beginning and end of the six-week trial and four months later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HD033988 | NIH | None | httpsreporternihgovquickSearchP01HD033988 |