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Sponsors and Collaborators: |
Hvidovre University Hospital University of Copenhagen Faculty of Pharmaceutical Sciences Universitetsparken 2 2100 Copenhagen Denmark |
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Information provided by: | Hvidovre University Hospital |
ClinicalTrials.gov Identifier: | NCT00791024 |
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 |
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Analgesia |
Drug: CRC-Pharma 001 Drug: lidocaine suspension |
Phase I Phase II |
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 |
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 |
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single arm: Experimental |
Drug: CRC-Pharma 001
50 mg
Drug: lidocaine suspension
5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.
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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).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ove Andersen, md, PhD | 36323335 ext +45 | ove.andersen@hvh.regionh.dk |
Denmark | |
Copenhagen University, Hvidovre Hospital | Recruiting |
Hvidovre, Denmark, 2650 | |
Contact: Billy Kristensen, MD, PhD 36322527 ext +45 Billy.Kristensen@hvh.regionh.dk |
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 |
Analgesia Tests Analog Pain Scale Pain Measurement |
Lidocaine Pain |
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 |