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N/A - KET MET study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012658-19-NL
Enrollment
48
Registered
2009-05-11
Start date
2009-08-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pain to be tested in healthy volunteers

Interventions

Trade Name: Ketanest-S Product Name: S(+)-ketamine Product Code: RVG22550 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: KETAMINE CAS Number: 6740881 Other descriptive name: Ketanest-S

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: healthy volunteers, aged 18-45 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Obesity (BMI > 35); Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia); Presence of psychiatric disease; History of chronic alcohol or illicit drug use;

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. The study the contribution of the NMDA receptor in the effect of methadon on pain rleief and respiratory depression 2. To study the contribution of the mu-opioid receptor in the effect of S(+)-ketamine on pain relief and respiratyory depression.;Secondary Objective: nonen;Primary end point(s): This study is aimed at quantifying the relative contribution of the two major receptor systems involved in S(+)-ketamine and methadone induced analgesia and side effects (respiratory depression, sedation, miosis).

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026