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Development of a New Method for Analgesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00791024
First received: November 12, 2008
Last updated: May 11, 2009
Last verified: November 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Phase One Study and Two of a New Method for Local Analgesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • VAS score [ Time Frame: at day O and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaire( examiner and patient) [ Time Frame: performed at day 0 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: November 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791024

Contacts
Contact: Ove Andersen, md, PhD 36323335 ext +45 ove.andersen@hvh.regionh.dk

Locations
Denmark
Copenhagen University, Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Billy Kristensen, MD, PhD     36322527 ext +45     Billy.Kristensen@hvh.regionh.dk    
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ove Andersen Scientific Director, PhD, Clinical Research Centre Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00791024     History of Changes
Other Study ID Numbers: CRC06
Study First Received: November 12, 2008
Last Updated: May 11, 2009
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
Analgesia Tests
Analog Pain Scale
Pain Measurement

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013