Complex Regional Pain Syndrome Type IPhase 2NCT00006289

Neurotropin to Treat Chronic Neuropathic Pain

A Phase 2 study testing Neurotropin in people with Complex Regional Pain Syndrome Type I and Complex Regional Pain Syndrome Type II, run by National Institute of Nursing Research (NINR) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome Type II
What is being tested?: Neurotropin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Sep 2000to Jun 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
All ethnic and racial groups can participate.
Patients must be willing to return to NIH for follow-up evaluation under this protocol.

Who cannot join

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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain

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.

Read the 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.

Conditions: Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome Type II
Being tested: Placebo, Neurotropin
Keywords: Analgesia, Causalgia, CRPS, Neuropathic Pain, Oral Surgery, Reflex Sympathetic Dystrophy, Sympathetic Nervous System, Chronic Regional Pain Syndrome
Medical subject headings: Complex Regional Pain Syndromes, Causalgia, Agnosia, Neuralgia, Reflex Sympathetic Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Also called Drug A
4 tabs b.i.d.
NeurotropinDrug
Also called Drug B
4 tabs b.i.d.

Study groups in NCT00006289
Study group	Role	What they receive
Placebo first, then Neurotropin (G-1)	Active comparator	Double blind cross-over study: receive placebo for 5 weeks and then Neurotropin for 5 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind. Receives: Drug: Placebo; Drug: Neurotropin
Neurotropin first, then Placebo (G-2)	Active comparator	Double blind cross-over study: receive Neurotropin for 5 weeks and then placebo for 5 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind. Receives: Drug: Placebo; Drug: Neurotropin

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )
Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Measured: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.
Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)
Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Measured: NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.
McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)
Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Measured: MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2000Jun 2012

First posted22 Sep 2000 (estimated)
Study startSep 2000
Primary completionJun 2012
Study completionJun 2012

Why it stopped: difficulty in the recruitment of patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Complex Regional Pain Syndrome Type IStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00006289
Sponsor's protocol ID: 000200
Other IDs: 00-NR-0200
Status last verified: Aug 2017
First submitted: 21 Sep 2000
Last updated: 22 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Stanton-Hicks M, Janig W, Hassenbusch S, Haddox JD, Boas R, Wilson P. Reflex sympathetic dystrophy: changing concepts and taxonomy. Pain. 1995 Oct;63(1):127-133. doi: 10.1016/0304-3959(95)00110-E.
PubMed 8577483
Galer BS, Bruehl S, Harden RN. IASP diagnostic criteria for complex regional pain syndrome: a preliminary empirical validation study. International Association for the Study of Pain. Clin J Pain. 1998 Mar;14(1):48-54. doi: 10.1097/00002508-199803000-00007.
PubMed 9535313
Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54. doi: 10.1016/s0304-3959(99)00011-1.
PubMed 10353502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
RecruitingObservational study
CRPS-RISE Outcomes Registry
Complex Regional Pain Syndrome I (CRPS I)
Recruiting
ESWT for CRPS-I After Distal Radius Fracture
Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture

All Complex Regional Pain Syndrome Type I trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain
ClinicalTrials.gov ID: NCT00006289
Acronym / sponsor ID: 000200
Conditions: Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome Type II
Keywords: Analgesia, Causalgia, CRPS, Neuropathic Pain, Oral Surgery, Reflex Sympathetic Dystrophy, Sympathetic Nervous System, Chronic Regional Pain Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: difficulty in the recruitment of patients
Enrolment: 21 participants (actual)
Lead sponsor: National Institute of Nursing Research (NINR)US National Institutes of Health
Collaborators: National Institutes of Health Clinical Center (CC), National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Sep 2000
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 22 Sep 2000 (estimated)
Results: Posted 21 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will examine the effectiveness of the drug neurotropin in treating chronic pain after injury to a limb or a large nerve.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo first, then Neurotropin (G-1)	Active comparator	Drug: Placebo, Drug: NeurotropinDouble blind cross-over study: receive placebo for 5 weeks and then Neurotropin for 5 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind.
Neurotropin first, then Placebo (G-2)	Active comparator	Drug: Placebo, Drug: NeurotropinDouble blind cross-over study: receive Neurotropin for 5 weeks and then placebo for 5 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.
All ethnic and racial groups can participate.
Patients must be willing to return to NIH for follow-up evaluation under this protocol.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAlso: Drug A4 tabs b.i.d.	Drug	Neurotropin first, then Placebo (G-2), Placebo first, then Neurotropin (G-1)
NeurotropinAlso: Drug B4 tabs b.i.d.	Drug	Neurotropin first, then Placebo (G-2), Placebo first, then Neurotropin (G-1)

Primary outcome

Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )
Time frame: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.
Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)
Time frame: NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.
Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)
Time frame: MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.
Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.

Results and safety

Results posted to the registry on 21 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then Neurotropin	11	10
Neurotropin First, Then Placebo	10	10

Primary outcome: Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )

Time frame: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.. Mean (Standard Error). Unit: mm

Measure	VAS After Placebo Treatment First in G-1 n = 7	VAS After Neurotropin Treatment Second in G-1 n = 7	VAS After Neurotropin Treatment First in G-2 n = 9	VAS After Placebo Treatment Second in G-2 n = 9
Value	33.6 (11.1)	38.3 (8.8)	36.0 (7.6)	31.1 (7.7)

VAS After Placebo Treatment First in G-1 vs VAS After Neurotropin Treatment Second in G-1 vs VAS After Neurotropin Treatment First in G-2 vs VAS After Placebo Treatment Second in G-2: p = 0.0058, t-test, 1 sided

Primary outcome: Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)

Time frame: NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.. Mean (Standard Deviation). Unit: units on a scale

Measure	NRS After Placebo Treatment First in G-1 n = 7	NRS After Neurotropin Treatment Second in G-1 n = 7	NRS After Neurotropin Treatment First in G-2 n = 9	NRS After Placebo Treatment Second in G-2 n = 9
Value	3.0 (1.1)	3.3 (0.9)	4.0 (0.8)	3.1 (0.8)

NRS After Placebo Treatment First in G-1 vs NRS After Neurotropin Treatment Second in G-1 vs NRS After Neurotropin Treatment First in G-2 vs NRS After Placebo Treatment Second in G-2: p = 0.0058, t-test, 1 sided

Primary outcome: McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)

Time frame: MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.. Mean (Standard Error). Unit: units on a scale

Measure	MPQ After Placebo Treatment First in G-1 n = 7	MPQ After Neurotropin Treatment Second in G-1 n = 7	MPQ After Neurotropin Treatment First in G-2 n = 9	MPQ After Placebo Treatment Second in G-2 n = 9
Value	22.4 (5.9)	33.1 (4.0)	25.4 (4.9)	27.1 (5.7)

MPQ After Placebo Treatment First in G-1 vs MPQ After Neurotropin Treatment Second in G-1 vs MPQ After Neurotropin Treatment First in G-2 vs MPQ After Placebo Treatment Second in G-2: p = 0.0058, t-test, 1 sided

Adverse events

Time frame: Adverse event information will be collected during the treatments and 5 weeks after the completion of study.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo First, Then Neurotropin	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
Neurotropin First, Then Placebo	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Because of the difficulty in patient recruitment, the interim analysis was performed for the first 16 patients (target was 30). The results are inconclusive due to large variations in pain scores associated with insufficient the number of patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8577483Stanton-Hicks M, Janig W, Hassenbusch S, Haddox JD, Boas R, Wilson P. Reflex sympathetic dystrophy: changing concepts and taxonomy. Pain. 1995 Oct;63(1):127-133. doi: 10.1016/0304-3959(95)00110-E.
Background: PubMed 9535313Galer BS, Bruehl S, Harden RN. IASP diagnostic criteria for complex regional pain syndrome: a preliminary empirical validation study. International Association for the Study of Pain. Clin J Pain. 1998 Mar;14(1):48-54. doi: 10.1097/00002508-199803000-00007.
Background: PubMed 10353502Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54. doi: 10.1016/s0304-3959(99)00011-1.

Related trials for Complex Regional Pain Syndrome Type I

Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
RecruitingObservational study
CRPS-RISE Outcomes Registry
Complex Regional Pain Syndrome I (CRPS I)
Recruiting
ESWT for CRPS-I After Distal Radius Fracture
Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leorey Saligan, PhD, CRNP principal investigator

National Institute of Nursing Research (NINR)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin ) (time frame: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006289, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.