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Completed

NCT Number: NCT00791024

Development of a New Method for 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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Copenhagen University, Hvidovre Hospital

Hvidovre, 2650, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe psychiatric diseases
  • Alcohol abuse

Treatment and study plan

CRC-Pharma 001

Drug

50 mg

lidocaine suspension

Drug

5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.

Primary outcomes

  1. VAS score

    Time frame: at day O and 3

Secondary outcomes

  1. Questionnaire( examiner and patient)

    Time frame: performed at day 0 and 3

Sponsors and collaborators

Lead sponsor

Ove Andersen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 14, 2008
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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