Development of a New Method for Analgesia

This study is currently recruiting participants.

Verified by Hvidovre University Hospital, November 2008

Sponsors and Collaborators:	Hvidovre University Hospital University of Copenhagen Faculty of Pharmaceutical Sciences Universitetsparken 2 2100 Copenhagen Denmark
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00791024

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 I Phase II

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase One Study and Two of a New Method for Local Analgesia

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
single arm: Experimental	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

Faculty of Pharmaceutical Sciences

Universitetsparken 2

2100 Copenhagen

Denmark

More Information

Responsible Party:	Clinical Research Centre Hvidovre University Hospital ( Ove Andersen Scientific Director, PhD )
Study ID Numbers:	CRC06
Study First Received:	November 12, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791024
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:

Analgesia Tests
Analog Pain Scale
Pain Measurement

Study placed in the following topic categories:

Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009