CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Fentanyl Buccal Tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01856114
NCT01856114Phase 2Completed

A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea

M.D. Anderson Cancer Center·interventional·Posted May 17, 2013·Updated Sep 16, 2020

In Brief

A Phase 2 clinical trial evaluating Fentanyl Buccal Tablet, Placebo Buccal Tablet, and 1 other intervention for Advanced Cancers. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 17, 2013
Enrollment StartMay 27, 2014
Primary CompletionDec 4, 2019
TodayJul 1, 2026
Enrollment to primary: 5.5 yearsPosted 13.1 years ago

Interventions

Fentanyl Buccal Tabletdrug

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

Placebo Buccal Tabletother

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

Questionnairesbehavioral

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.