Development of a New Method for Analgesia

Phase One Study and Two of a New Method for Local Analgesia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00791024

Enrollment

126

Registered

2008-11-14

Start date

2008-11-30

Completion date

2010-01-31

Last updated

2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

Analgesia Tests, Analog Pain Scale, Pain Measurement

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).

Interventions

DRUGCRC-Pharma 001

50 mg

DRUGlidocaine suspension

5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients admitted for adipositas surgery * Patients who attend for oesophagogastroduodenoscopy.

Exclusion criteria

* Severe psychiatric diseases * Alcohol abuse

Design outcomes

Primary

Measure	Time frame
VAS score	at day O and 3

Secondary

Measure	Time frame
Questionnaire( examiner and patient)	performed at day 0 and 3

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026