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TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

This study has been withdrawn prior to enrollment.
(No participants enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02031211
First Posted: January 9, 2014
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Srinivas Naidu, Stanford University
  Purpose
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.

Condition Intervention
CRPS Chronic Regional Pain Syndrome Drug: Etanercept Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Etanercept for the Treatment of Chronic Regional Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Srinivas Naidu, Stanford University:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 8 weeks ]
    intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.


Secondary Outcome Measures:
  • Adolescent Pediatric Pain Tool [ Time Frame: At end of each week of treatment ]
    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.

  • Skin Temperature and Volume of Affected Limb [ Time Frame: At beginning and end of study ]
    The skin temperature and volume of the affected limb will be measured at the beginning and end of the study.

  • Hospital Anxiety and Depression Scale [ Time Frame: Beginning and end of study ]
    The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study.

  • Sleep Disturbance Scale for Children [ Time Frame: Beginning and end of the study ]
    The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study.

  • Sleep pattern and quality [ Time Frame: Daily ]
    The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.


Enrollment: 0
Study Start Date: June 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0.4 ml/kg of normal saline will be administered subcutaneously.
Drug: Placebo
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
Other Name: Normal Saline
Experimental: Etanercept
Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.
Drug: Etanercept
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
Other Name: Enbrel

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031211


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
  More Information

Responsible Party: Srinivas Naidu, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02031211     History of Changes
Other Study ID Numbers: 29290
First Submitted: January 7, 2014
First Posted: January 9, 2014
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors