CRPSNCT02031211
TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial
A study testing Etanercept in people with CRPS and Chronic Regional Pain Syndrome, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years, women only
- Conditions the study is for
- CRPS, Chronic Regional Pain Syndrome
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
- 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.
- Duration of symptoms less than 4 months.
Who cannot join
- Active malignancy or history of malignancy.
- Active infection.
- History of Tuberculosis (TB) or TB exposure.
- Pregnancy.
- Concomitant disease causing immunocompromise.
- Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.
Show all 9Show fewer
- Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.
- Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age.
- Evidence of or history of demyelinating disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etanercept for the Treatment of Chronic Regional Pain Syndrome
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.
- Conditions
- CRPS, Chronic Regional Pain Syndrome
- Being tested
- Etanercept, Placebo
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
PlaceboDrug
Also called Normal Saline
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.4 ml/kg of normal saline will be administered subcutaneously. Receives: Drug: Placebo |
| Etanercept | Experimental | Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: At end of each week of treatment
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.
Measured: At beginning and end of study
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.
Measured: Beginning and end of study
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.
Measured: Beginning and end of the study
Sleep pattern and quality
The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPSStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivas Naidu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031211
- Sponsor's protocol ID
- 29290
- Status last verified
- Oct 2016
- First submitted
- 7 Jan 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etanercept for the Treatment of Chronic Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT02031211
- Acronym / sponsor ID
- 29290
- Conditions
- CRPS, Chronic Regional Pain Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo0.4 ml/kg of normal saline will be administered subcutaneously. |
| Etanercept | Experimental | Drug: EtanerceptPatient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
- 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.
- Duration of symptoms less than 4 months.
Key exclusion criteria (9 listed)
- Active malignancy or history of malignancy.
- Active infection.
- History of Tuberculosis (TB) or TB exposure.
- Pregnancy.
- Concomitant disease causing immunocompromise.
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 |
|---|---|---|
| EtanerceptAlso: EnbrelThe patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously. | Drug | Etanercept |
| PlaceboAlso: Normal SalineThe patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Adolescent Pediatric Pain Tool
Time frame: At end of each week of treatment
Skin Temperature and Volume of Affected Limb
Time frame: At beginning and end of study
Hospital Anxiety and Depression Scale
Time frame: Beginning and end of study
Sleep Disturbance Scale for Children
Time frame: Beginning and end of the study
Sleep pattern and quality
Time frame: Daily
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept in people with CRPS and Chronic Regional Pain Syndrome, run by Stanford University at 1 site in United States.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Oct 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Analog Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.