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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00255138
Other study ID # 4463
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date November 2005

Study information

Verified date March 2022
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties. Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - No ongoing pharmacological management of ADHD - Not currently pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atomoxetine


Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conner's Parent Rating Scale (CPRS)
Secondary Conner's Teacher Rating Scale (CTRS)
Secondary Continuous Performance Test (CPT)
Secondary Side Effects Rating Scale
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