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Neurotropin to Treat Chronic Neuropathic Pain
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008
First Received: September 21, 2000   Last Updated: October 4, 2008   History of Changes
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006289
  Purpose

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.


Condition Intervention Phase
Causalgia
Reflex Sympathetic Dystrophy
Drug: Neurotropin
Phase II

MedlinePlus related topics: Complex Regional Pain Syndrome
Drug Information available for: Neurotropin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Reduction in post-operative requirement for the usual analgesic and reduction of the severity of pain. [ Time Frame: 2 days post extraction; 21 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2000
Arms Assigned Interventions
1: Placebo Comparator
Dental Pts: 4 tablets orally at 6 hr intervals for 48 hours to supplement a standard analgesic.@@@Chronic Pain Pts: 4 tablets orally twice daily for 5 weeks.
Drug: Neurotropin
Double Blind study
2: Active Comparator
Dental Pts: 4 tablets orally at 6 hr intervals for 48 hrs to supplement a standard analgesic.@@@Chronic Pain Pts: 4 tablets orally twice daily for 5 weeks.
Drug: Neurotropin
Double Blind study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • IINCLUSION CRITERIA

Dental outpatients undergoing elective removal of impacted third molars based on a preoperative diagnosis of the type and number of teeth to be extracted. The difficulty of extraction will be classified based on clinical exam and a panoramic radiograph as simple extraction (1), soft tissue impaction (2), partial boney impaction (3), or full boney impaction (4). Both lower teeth to be extracted should be similarly boney impacted, and the score for each of the two lower teeth should be 3 to 4. Uppers are usually in soft tissue. The diagnosis for each tooth will be confirmed by the oral surgeon after the procedure based on the surgical procedure actually performed.

CRPS patients are referred with a diagnosis of CRPS-I or CRPS-II in one limb only, based on pain (1) that is post-traumatic and spread beyond the region of the injury; (2) has persisted for more than 2 weeks; and (3) is associated with swelling, altered skin color or skin temperature, altered sweating, allodynia or hyperesthesia or limitation of active movement. Atrophic changes in skin, hair loss or nail changes, or disuse atrophy of skeletal muscle may be present.

Both sexes are to be studied.

Children can participate, if they can provide adequate self-ratings.

All ethnic and racial groups can participate.

Patients must be willing to return to NIH for follow-up evaluation under this protocol.

EXCLUSION CRITERIA

Dental outpatients must not be taking any medications chronically (with the exception of oral contraceptive agents).

Pregnant and lactating women are excluded.

Based on the oral surgeon's postoperative diagnosis, any extraction which is classified as producing unusual surgical trauma will result in exclusion from the remainder of the study.

Dental subjects will also be excluded if they are not adequately sedated by midazolam alone and require intraoperative administration of an opioid drug such as fentanyl, administration of greater than 14.4 ml of local anesthetic (2% lidocaine with 1:100,000 epinephrine), or postoperative administration of a steroid for possible injury to the inferior alveolar nerve.

Patients referred with CRPS-I or CRPS II who have abnormal screening test results or who have non-traumatic disorders to which pain may be attributed (gout, malignancy, arthritis, etc.) will be excluded.

Any patients who have had ablative procedures for treatment of their neuropathic pain disorder will not be eligible for inclusion in this study.

Subjects with impaired mental capacity that precludes informed consent and children who cannot provide adequate self-ratings are excluded.

Patients who have a positive HIV result will be excluded.

Subjects with obviously impaired mental capacity that precludes informed consent and ability to provide adequate self-ratings are to be excluded.

Patients who have a positive HIV result will be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006289

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health ( Raymond A. Dionne Jr., D.D.S./National Institutes of Nursing Research )
Study ID Numbers: 000200, 00-NR-0200
Study First Received: September 21, 2000
Last Updated: October 4, 2008
ClinicalTrials.gov Identifier: NCT00006289     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Analgesia
Causalgia
CRPS
Neuropathic Pain
Oral Surgery
Reflex Sympathetic Dystrophy
Sympathetic Nervous System
Chronic Regional Pain Syndrome

Study placed in the following topic categories:
Reflex Sympathetic Dystrophy
Neuralgia
Immunologic Factors
Toothache
Neurotropin
Adjuvants, Immunologic
Pain
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Causalgia
Reflex Sympathetic Dystrophy Syndrome
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:
Reflex Sympathetic Dystrophy
Neuralgia
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Neurotropin
Adjuvants, Immunologic
Pharmacologic Actions
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Causalgia
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009