NCT00255138

Brief Summary

The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

First QC Date

November 15, 2005

Last Update Submit

March 30, 2022

Conditions

CancerCognitive Late Effects

Keywords

CancerCognitive Late EffectsStimulantsAtomoxetineAttentionChildren

Outcome Measures

Primary Outcomes (1)

  • Conner's Parent Rating Scale (CPRS)

Secondary Outcomes (3)

  • Conner's Teacher Rating Scale (CTRS)

  • Continuous Performance Test (CPT)

  • Side Effects Rating Scale

Interventions

AtomoxetineDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6-18
  • Patient has received chemotherapy, radiation, or a combination of both.
  • Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.

You may not qualify if:

  • No ongoing pharmacological management of ADHD
  • Not currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Atomoxetine Hydrochloride

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Ronald T Brown, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

November 1, 2005

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

US(1)