NCT00791024

Development of a New Method for Analgesia

Phase One Study and Two of a New Method for Local Analgesia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Ove Andersen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

Detailed description

A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	CRC-Pharma 001	50 mg
DRUG	lidocaine suspension	5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2010-01-01
• First posted: 2008-11-14
• Last updated: 2015-08-26

Locations

1 site across 1 country: Denmark