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NCT00791024 Clinical Trial

Development of a New Method for Analgesia

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00791024
Other study ID # CRC06
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 12, 2008
Last updated August 25, 2015
Start date November 2008
Est. completion date January 2010

Study information
Verified date August 2015
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date January 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients admitted for adipositas surgery

- Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria:

- Severe psychiatric diseases

- Alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• CRC-Pharma 001
50 mg
• lidocaine suspension
5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.

Locations
Country Name City State
Denmark Copenhagen University, Hvidovre Hospital Hvidovre

Sponsors (2)
Lead Sponsor Collaborator
Ove Andersen University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score at day O and 3 No
Secondary Questionnaire( examiner and patient) performed at day 0 and 3 No
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