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Urinary Excretion of Acetylamantadine by Cancer Patients

Phase 2
18 Years
Not Enrolling

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Trial Information

Urinary Excretion of Acetylamantadine by Cancer Patients

When patients present to their physician with symptoms of cancer at a later stage of
development, survival tends to be poorer. Earlier diagnosis of cancer is expected to
provide improved survival of patients due to earlier treatment intervention. However,
implementation of this screening process is impaired by access and by cost. A simple and
inexpensive test would serve as a screening tool that could be safely repeated at regular
intervals to identify persons for whom more expensive and less accessible diagnostic
investigations might become more appropriately directed. The specificity for an enzyme that
increases markedly in cancer tissue, and the ease of administration of an already licensed
pharmaceutical prescription product, amantadine hydrochloride, would appear to provide
promise of such a desirable screening test.

Inclusion Criteria:

- Either a medical diagnosis of cancer, or determination of general good health after a
medical check-up within two weeks of participation in the study

Exclusion Criteria:

- Allergy to amantadine hydrochloride

- Chronic liver or kidney disease

- Chronic disease state not controlled by drug therapy, e.g. hypertension

- Pregnancy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a single oral dose of amantadine hydrochloride ingested two hours after supper

Outcome Time Frame:

12 hours

Safety Issue:


Principal Investigator

Daniel S Sitar, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manitoba


Canada: Health Canada

Study ID:




Start Date:

December 2003

Completion Date:

July 2008

Related Keywords:

  • Cancer
  • cancer
  • diagnostic test
  • urine
  • amantadine acetylation