MedTrace Logo

Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea

NCT01856114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-09-16

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. In this study, fentanyl will be compared to a placebo.

Fentanyl is commonly used for treatment of cancer pain.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Conditions

Interventions

DRUG

Fentanyl Buccal Tablet

Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.

OTHER

Placebo Buccal Tablet

Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.

BEHAVIORAL

Questionnaires

Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Hui, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-27
Primary Completion
2019-12-04
Completion
2019-12-04
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 NCT01856114 on ClinicalTrials.gov