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Sickle Cell Pain: Intervention With Capsaicin Exposure

NCT03899246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-29

No results posted yet for this study

Summary

This study evaluates the safety and feasibility of using high dose topical capsaicin patches for the treatment of neuropathic pain in pediatric patients with sickle cell disease, as well as the feasibility of using a number of tests for the evaluation and monitoring of neuropathic pain. The hypothesis, based on evidence obtained from studies in adults with neuropathic pain related to other diseases as well as a single previously published study of capsaicin in pediatric patients, is that capsaicin will be well tolerated in this population. Additionally, it is hypothesized that it is feasible to monitor changes in neuropathic pain via the testing listed below.

Conditions

Interventions

DRUG

Eight Percent Topical Capsaicin

See arm description

Sponsors & Collaborators

  • Children's Hospital of Michigan

    lead OTHER

Principal Investigators

  • Alexander K Glaros, MD · Children's Hospital of Michigan

  • Ahmar U Zaidi, MD · Children's Hospital of Michigan

  • Callaghan Michael, MD · Children's Hospital of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899246 on ClinicalTrials.gov