The effect of high-dose remifentanil on the reversal of established capsaicin-induced hyperalgesia in human volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011599-31-AT

Enrollment

Unknown

Registered

2009-04-21

Start date

2009-06-26

Completion date

Unknown

Last updated

2016-11-21

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

Conditions

This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP ist studied

Interventions

Trade Name: Ultiva Product Name: Remifentanil Product Code: N01AH06 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: • Men or women, aged between 19 and 40 years • Body mass index between 15th and 85th percentile • Normal findings in the medical history and physical examination • Drug free for 1 week prior to the study day 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: Any of the following will exclude a subject from the study: • Regular use of medication especially analgesics, • Abuse of alcoholic beverages, drug abuse • History of asthma • Participation in a clinical trial in the 2 weeks preceding the study • Symptoms of a clinically relevant illness in the 2 weeks before the first study day • Resting systolic blood pressure >135 mmHg or diastolic blood pressure >85 mmHg • Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the reversal of established hyperalgesia The main outcome variable will be: area of pin prick hyperalgesia ;Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be: Stimulus response (SR-)function to set of modified rigid Frey filaments, area of dynamic allodynia to brush. Heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variable. ;Primary end point(s): Area of pinprick hyperalgesia 6 hours after discontinuation of IMP	—

Measure

Time frame

Main Objective: To study the reversal of established hyperalgesia The main outcome variable will be: area of pin prick hyperalgesia ;Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be: Stimulus response (SR-)function to set of modified rigid Frey filaments, area of dynamic allodynia to brush. Heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variable. ;Primary end point(s): Area of pinprick hyperalgesia 6 hours after discontinuation of IMP

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Countries

Austria

Outcome results

None listed

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