Development of a New Method for Analgesia

Phase 1

Completed

• Conditions: Analgesia
• Interventions: Drug: CRC-Pharma 001; Drug: lidocaine suspension

• Registration Number: NCT00791024
• Lead Sponsor: Ove Andersen

Brief 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).

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Patients admitted for adipositas surgery
• Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria

• Severe psychiatric diseases
• Alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single arm	CRC-Pharma 001	-
single arm	lidocaine suspension	-

Primary Outcome Measures

Name	Time	Method
VAS score	at day O and 3

Secondary Outcome Measures

Name	Time	Method
Questionnaire( examiner and patient)	performed at day 0 and 3

Trial Locations

Locations (1)

Copenhagen University, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark