Recruiting
Phase 1
Phase 2

Amantadine

Sponsor:

University Health Network, Toronto

Code:

NCT00188383

Conditions

Hyperalgesia

Pain

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Amantadine

Study Details

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

Conditions

Hyperalgesia

Pain

Prostate Cancer

Study ID

NCT00188383

Start date

Jan, 2004

Status verified date

Sep, 2005

Completion date

Dec, 2006

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Significant central nervous system (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae;
2. Contraindications, allergies to, and/or past adverse reactions to opioid analgesics, amantadine or nonsteroidal anti-inflammatory drugs (NSAIDS);
3. 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;
4. History of epilepsy or other seizures;
5. History of chronic pain of at least 6 months duration;
6. History of long term opioid use for chronic pain of at least 6 months duration;
7. History of long term use of amantadine or other antiparkinsonian drug;
8. Ingestion of antitussive medication (dextromethorphan) within the 48 hours before surgery;
9. History of alcohol or drug dependency/abuse of at least 6 months duration

Study Design

Enrollment

132 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Educational/Counseling/Training

Interventions and Outcome Measures

Interventions

Amantadine

Primary outcome measure

  • To investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Lucia Gagliese, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 14, 2006

Last verified

Sep, 2005

Keywords

  • Hyperalgesia
  • Quantitative Sensory Testing
  • Pain
  • Opioid use
  • Elderly

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2006-03-14.