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Development of a New Method for Analgesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791024
First Posted: November 14, 2008
Last Update Posted: August 26, 2015
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.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital
  Purpose
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 Intervention Phase
Analgesia Drug: CRC-Pharma 001 Drug: lidocaine suspension Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ove Andersen, Hvidovre University Hospital:

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

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

Enrollment: 126
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Drug: CRC-Pharma 001
50 mg
Drug: lidocaine suspension
5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
Denmark
Copenhagen University, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Ove Andersen
University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ove Andersen, Research director, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00791024     History of Changes
Other Study ID Numbers: CRC06
First Submitted: November 12, 2008
First Posted: November 14, 2008
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:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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