Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02031211
Other study ID # 29290
Secondary ID
Status Withdrawn
Phase N/A
First received January 7, 2014
Last updated October 12, 2016
Start date June 2014
Est. completion date October 2016

Study information

Verified date October 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria:

1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.

2. Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb =1.0°C.

3. Duration of symptoms less than 4 months.

Exclusion Criteria:

1. Active malignancy or history of malignancy.

2. Active infection.

3. History of Tuberculosis (TB) or TB exposure.

4. Pregnancy.

5. Concomitant disease causing immunocompromise.

6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.

7. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.

8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine = 150% normal value for age.

9. Evidence of or history of demyelinating disease.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Etanercept
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
Placebo
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.

Locations

Country Name City State
United States Stanford University Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups. 8 weeks No
Secondary Adolescent Pediatric Pain Tool The Adolescent Pediatric Pain Tool is a survey that will be administered at baseline and at the end of each of the four weeks of treatment. At end of each week of treatment No
Secondary Skin Temperature and Volume of Affected Limb The skin temperature and volume of the affected limb will be measured at the beginning and end of the study. At beginning and end of study No
Secondary Hospital Anxiety and Depression Scale The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study. Beginning and end of study No
Secondary Sleep Disturbance Scale for Children The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study. Beginning and end of the study No
Secondary Sleep pattern and quality The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality. Daily No
See also
  Status Clinical Trial Phase
Recruiting NCT00377468 - Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study) Phase 2
Completed NCT01618578 - The Rubber Hand Illusion (RHI) in Patients With CRPS N/A
Completed NCT02467556 - Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome Phase 4
Recruiting NCT01601925 - Distances From Cricoid Cartilage to the Targets of Stellate Ganglion Block N/A
Withdrawn NCT04709757 - Comparison of Continuous and Burst High Frequency Spinal Cord Stimulation Paradigms N/A
Completed NCT00558753 - Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA Phase 2
Active, not recruiting NCT05473338 - Complex Regional Pain Syndrome (CRPS) and the Gut-bacteria