Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006289
Status:
TERMINATED
Last Update Posted:
2017-08-22
First Post:
2000-09-21
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:
TERMINATED
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:
This study will examine the effectiveness of the drug neurotropin in treating chronic pain after injury to a limb or a large nerve
Two groups of patients will participate in this study patients with complex regional pain syndrome type 1 or CRPS-I also called reflex sympathetic dystrophy and patients with complex regional pain syndrome type 2 or CRPS-II CRPS-I is pain that develops after relatively minor injury to an arm or leg but lasts much longer and is much more severe than would normally be expected CRPS-II is pain resulting from injury to a large nerve Candidates will have a history and physical examination blood tests and electrocardiogram Participants will undergo the following tests and procedures
Patients with CRPS I and II will receive an individualized regimen of physical therapy and standard treatment to control their pain In addition they will receive neurotropin or placebo tablets for 5 weeks then no trial medicine for at least 1 week and then the other trial drug for the next 5 weeks That is patients who took placebo the first 5 weeks will take neurotropin the second 5 weeks and vice versa Neither the patients nor the doctors will know who received which drug during the two intervals until the study is over Patients will complete questionnaires about their pain quality of life and ability to perform daily living activities They will have various tests to measure pain such as sensitivity to heat and cold to an electric current to a mild pin prick etc to provide information about changes in their condition such as tests of range of motion of joints and limb size to measure blood circulation and sweating in the arm or leg such as measurements of blood flow to the limb skin temperature and sweat production and other procedures
Two groups of patients will participate in this study patients with complex regional pain syndrome type 1 or CRPS-I also called reflex sympathetic dystrophy and patients with complex regional pain syndrome type 2 or CRPS-II CRPS-I is pain that develops after relatively minor injury to an arm or leg but lasts much longer and is much more severe than would normally be expected CRPS-II is pain resulting from injury to a large nerve Candidates will have a history and physical examination blood tests and electrocardiogram Participants will undergo the following tests and procedures
Patients with CRPS I and II will receive an individualized regimen of physical therapy and standard treatment to control their pain In addition they will receive neurotropin or placebo tablets for 5 weeks then no trial medicine for at least 1 week and then the other trial drug for the next 5 weeks That is patients who took placebo the first 5 weeks will take neurotropin the second 5 weeks and vice versa Neither the patients nor the doctors will know who received which drug during the two intervals until the study is over Patients will complete questionnaires about their pain quality of life and ability to perform daily living activities They will have various tests to measure pain such as sensitivity to heat and cold to an electric current to a mild pin prick etc to provide information about changes in their condition such as tests of range of motion of joints and limb size to measure blood circulation and sweating in the arm or leg such as measurements of blood flow to the limb skin temperature and sweat production and other procedures
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 |