Development of a New Method for Analgesia

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00791024
First received: November 12, 2008
Last updated: August 25, 2015
Last verified: August 2015
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791024

Locations
Denmark
Copenhagen University, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Ove Andersen
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, Research director, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00791024     History of Changes
Other Study ID Numbers: CRC06
Study First Received: November 12, 2008
Last Updated: August 25, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on September 01, 2015