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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.
 
ClinicalTrials.gov Identifier: NCT00791024
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Analgesia Drug: CRC-Pharma 001 Drug: lidocaine suspension Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Phase One Study and Two of a New Method for Local Analgesia
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm Drug: CRC-Pharma 001
50 mg

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


Outcome Measures
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Primary Outcome Measures :
  1. VAS score [ Time Frame: at day O and 3 ]

Secondary Outcome Measures :
  1. Questionnaire( examiner and patient) [ Time Frame: performed at day 0 and 3 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe psychiatric diseases
  • Alcohol abuse
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791024


Locations
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Denmark
Copenhagen University, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Ove Andersen
University of Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ove Andersen, Research director, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00791024    
Other Study ID Numbers: CRC06
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by Ove Andersen, Hvidovre University Hospital:
Analgesia Tests
Analog Pain Scale
Pain Measurement
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action