Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03267277 · ClinicalTrials.gov registry record · Phase 2
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
A Phase 2 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03267277 is a Phase 2 study that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 15 participants.
The verdict
NCT03267277, a Phase 2 study, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it. Objective: To test if sodium thiosulfate (STS) can treat people with DM with calcinosis. Eligibility: People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs. Design: Participants will be screened with: * Medical history * Physical exam * Muscle strength and function tests * Blood and urine tests Participants will have several visits: * 7-day pre-treatment visit about 10 weeks before starting STS * Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions. * 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS. Visits may include repeats of screening tests and: * Questionnaires * Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent. * Durometry: A small instrument applies pressure on the skin or exposed calcinosis. * Measurements of blood flow in the arms and fingernail blood vessels * Photographs of the skin * Kidney ultrasound * Tests of kidney function * Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.
Interventions
- DRUG Sodium Thiosulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03267277
The ClinicalTrials.gov registry entry for NCT03267277 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium Thiosulfate is the first listed.
NCT03267277 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03267277 about?
NCT03267277 is a clinical study titled "Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis". Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn m...
What is the current status of trial NCT03267277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2017-10-05. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT03267277?
The interventions under investigation include: Sodium Thiosulfate (DRUG).
Who is sponsoring clinical trial NCT03267277?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.