Development of a New Method for Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791024
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : August 26, 2015
University of Copenhagen
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital

November 12, 2008
November 14, 2008
August 26, 2015
November 2008
November 2009   (Final data collection date for primary outcome measure)
VAS score [ Time Frame: at day O and 3 ]
Same as current
Complete list of historical versions of study NCT00791024 on Archive Site
Questionnaire( examiner and patient) [ Time Frame: performed at day 0 and 3 ]
Same as current
Not Provided
Not Provided
Development of a New Method for Analgesia
Phase One Study and Two of a New Method for Local Analgesia
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.
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).
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
  • Drug: CRC-Pharma 001
    50 mg
  • Drug: lidocaine suspension
    5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.
Experimental: single arm
  • Drug: CRC-Pharma 001
  • Drug: lidocaine suspension
Mogensen S, Pulis S, Kristensen BB, Ravn L, Treldal C, Rasmussen M, Mogensen T, Andersen O. A new method to facilitate oro-tracheal intubation of awake patients: a pilot study. Eur J Anaesthesiol. 2012 Nov;29(11):546-7. doi: 10.1097/EJA.0b013e328357e4e5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2010
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe psychiatric diseases
  • Alcohol abuse
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Ove Andersen, Hvidovre University Hospital
Ove Andersen
University of Copenhagen
Not Provided
Hvidovre University Hospital
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP