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Klinische Prüfung von Acoin im Vergleich zu Tetracain bei Patienten, die sich einer Bronchoskopie unterziehen müssen (Clinical trial with Acoin as compared with tetracaine in patients who have to undergo a bronchoscopy) - N/A

Klinische Prüfung von Acoin im Vergleich zu Tetracain bei Patienten, die sich einer Bronchoskopie unterziehen müssen (Clinical trial with Acoin as compared with tetracaine in patients who have to undergo a bronchoscopy) - N/A

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001491-13-DE
Enrollment
100
Registered
2005-12-02
Start date
2005-09-01
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

Patients who have to undergo bronchoscopy for diagnostic reasons, ie ICD classification cannot be stated

Interventions

Trade Name: Acoin (R) Lösung Product Name: Acoin Product Code: N/A Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tetracaine CAS Number: 136-47-0 Concentration unit: mg/ml milligram(s)/m

Sponsors

Combustin Pharmazeutische Präparate GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age range: 18-75 years, medical cecessity of a bronchoscopy, informed written consent, male and female patients 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No informed written consent; pregnancy; breast feeding period; hypersensitivity to ingredients.congestive heart failure; legal incapacity; conduction disturbances

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Efficacy:Malaise, retching irritation, cough and cough irritation Safety: Global judgements (physician, patient), influence on vital signs, methaemoglobine level, adverse events;Main Objective: Evaluation of the anaesthetic potency of Acoin (Tetracain+Polidocanol) in comparison with tetracaine alone with respect to the extent of irritation free anaesthesia.;Primary end point(s): Extent of irritation free anaesthesia as documented by the investigator by means of a visual analogue scale (VAS)—

Countries

Germany

Outcome results

None listed

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