NCT00188383

Brief Summary

The primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, the researchers propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found. The specific objectives of the study are to:

  1. 1.investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men
  2. 2.assess age differences in the intensity and course of secondary hyperalgesia after surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 14, 2006

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

March 13, 2006

Conditions

HyperalgesiaPainProstate Cancer

Keywords

HyperalgesiaQuantitative Sensory TestingPainOpioid useElderly

Outcome Measures

Primary Outcomes (1)

  • To investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men

Secondary Outcomes (1)

  • To assess age differences in the intensity and course of secondary hyperalgesia after surgery

Interventions

AmantadineDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read and write English;
  • Age 18-59 or \>= 60 years;
  • American Society of Anesthesiologists Class 1 to 3;
  • Scheduled for elective radical prostatectomy;
  • Body weight between 50-110 kg, body mass index (BMI) \<= 30.

You may not qualify if:

  • Significant central nervous system (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae;
  • Contraindications, allergies to, and/or past adverse reactions to opioid analgesics, amantadine or nonsteroidal anti-inflammatory drugs (NSAIDS);
  • Current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) Axis I disorder or cognitive dysfunction or history of this within the last year;
  • History of epilepsy or other seizures;
  • History of chronic pain of at least 6 months duration;
  • History of long term opioid use for chronic pain of at least 6 months duration;
  • History of long term use of amantadine or other antiparkinsonian drug;
  • Ingestion of antitussive medication (dextromethorphan) within the 48 hours before surgery;
  • History of alcohol or drug dependency/abuse of at least 6 months duration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

HyperalgesiaPainProstatic Neoplasms

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Lucia Gagliese, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Gagliese, PhD

CONTACT

416-340-4800lucia.gagliese@uhn.on.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

March 14, 2006

Record last verified: 2005-09

Locations

CA(1)