CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 enrolled
Drug / intervention
methylphenidate hydrochloride +1 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/NCT00376675
NCT00376675Phase 3Completed
CompareCT.gov

Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study

Alliance for Clinical Trials in Oncology·interventional·Posted Sep 15, 2006·Updated Aug 1, 2016

In Brief

A Phase 3 clinical trial evaluating methylphenidate hydrochloride and placebo for Fatigue and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 148 participants across 238 sites.

Detailed Summary

RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer. PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2006
Enrollment StartFeb 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.8 years ago

Interventions

methylphenidate hydrochloridedrug

Given orally

placeboother

Given orally