NCT00791024
Completed
Phase 1
Phase One Study and Two of a New Method for Local Analgesia
Ove Andersen1 site in 1 country126 target enrollmentNovember 2008
ConditionsAnalgesia
Overview
- Phase
- Phase 1
- Intervention
- CRC-Pharma 001
- Conditions
- Analgesia
- Sponsor
- Ove Andersen
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- VAS score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
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).
Investigators
Ove Andersen
Research director
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients admitted for adipositas surgery
- •Patients who attend for oesophagogastroduodenoscopy.
Exclusion Criteria
- •Severe psychiatric diseases
- •Alcohol abuse
Arms & Interventions
single arm
Intervention: CRC-Pharma 001
single arm
Intervention: lidocaine suspension
Outcomes
Primary Outcomes
VAS score
Time Frame: at day O and 3
Secondary Outcomes
- Questionnaire( examiner and patient)(performed at day 0 and 3)
Study Sites (1)
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