CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone 4 mgfrom 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/NCT01248585
NCT01248585Phase 3Completed
CompareCT.gov

A Randomized Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

NCIC Clinical Trials Group·interventional·Posted Nov 25, 2010·Updated Aug 28, 2023

In Brief

A Phase 3 clinical trial evaluating Dexamethasone and Placebo for Bone Metastases. Completed, enrolled 298 participants across 22 sites.

Detailed Summary

This research is being done because is is not known if dexamethasone can prevent pain flare (their pain temporarily gets worse before it gets better) caused by the radiation used to treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied in a few people and seems promising, but it is not clear if it can decrease the pain or prevent the pain flare before it happens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2010
Enrollment StartMay 30, 2011
Primary CompletionMay 25, 2015
Study CompletionNov 27, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 15.6 years ago

Interventions

Dexamethasonedrug

2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days

Placebodrug

2 placebo tablets taken once daily for 5 days