MedTrace Logo

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

NCT03661892 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-04-29

No results posted yet for this study

Summary

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

Conditions

Interventions

DRUG

Syndros

As noted in arm description. For patients who have side effects secondary to Sydnros, the dose will be decreased as below: Dose subject is taking Reduction recommendation 8.4mg BID Decreased to 8.4mg AM , 4.2mg PM (or it can be 4.2g in AM and 8.4mg in PM- depending on their side effect timing) 8.4mg AM, 4.2mg PM (or vice versa) 4.2mg BID 4.2mg BID 4.2mg once a day 4.2mg once a day Stop and take off study

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Pavani Chalasani, MD · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2020-10-30
Completion
2021-04-26
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 NCT03661892 on ClinicalTrials.gov