Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2025-12-16 @ 10:30 PM
Study NCT ID:
NCT00006289
Status:
None
Last Update Posted:
2017-08-22 00:00:00
First Post:
2000-09-21 00:00:00
Brief Title:
Neurotropin to Treat Chronic Neuropathic Pain
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center (CC)
Study Overview
Official Title:
Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain
Status:
None
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty in the recruitment of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with Reflex Sympathetic Dystrophy (RSD), re-named Complex Regional Pain Syndrome, type I (CRPS-I), have chronic, post-traumatic pain that spreads beyond the distribution of any single peripheral nerve without evidence of major peripheral nerve damage. A similar disorder, Causalgia, re-named CRPS-II, presents with clear evidence of nerve injury. No successful drug treatment exists for these disorders. Neurotropin is a non-protein extract of cutaneous tissue from rabbits inoculated with vaccinia virus. Neurotropin has been used extensively in Japan to treat RSD and other painful conditions; however, the drug has not undergone clinical therapeutic testing in the United States. This protocol is to carry out double-blind, placebo-controlled, crossover studies about clinical efficacy of Neurotropin for acute pain in dental outpatients and for chronic pain in outpatients with CRPS-I or II.
Detailed Description:
Patients with Reflex Sympathetic Dystrophy RSD re-named Complex Regional Pain Syndrome type I CRPS-I have chronic post-traumatic pain that spreads beyond the distribution of any single peripheral nerve without evidence of major peripheral nerve damage A similar disorder Causalgia re-named CRPS-II presents with clear evidence of nerve injury No successful drug treatment exists for these disorders Neurotropin is a non-protein extract of cutaneous tissue from rabbits inoculated with vaccinia virus Neurotropin has been used extensively in Japan to treat RSD and other painful conditions however the drug has not undergone clinical therapeutic testing in the United States This protocol is to carry out double-blind placebo-controlled crossover studies about clinical efficacy of Neurotropin for acute pain in dental outpatients and for chronic pain in outpatients with CRPS-I or II
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 |
|---|---|---|---|
| 00-NR-0200 | OTHER | NIH | None |