NCT00791024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

November 12, 2008

Last Update Submit

August 25, 2015

Conditions

Analgesia

Keywords

Analgesia TestsAnalog Pain ScalePain Measurement

Outcome Measures

Primary Outcomes (1)

  • VAS score

    at day O and 3

Secondary Outcomes (1)

  • Questionnaire( examiner and patient)

    performed at day 0 and 3

Study Arms (1)

single arm

EXPERIMENTAL
Drug: CRC-Pharma 001Drug: lidocaine suspension

Interventions

CRC-Pharma 001DRUG

50 mg

single arm
lidocaine suspensionDRUG

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

single arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe psychiatric diseases
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Mogensen S, Pulis S, Kristensen BB, Ravn L, Treldal C, Rasmussen M, Mogensen T, Andersen O. A new method to facilitate oro-tracheal intubation of awake patients: a pilot study. Eur J Anaesthesiol. 2012 Nov;29(11):546-7. doi: 10.1097/EJA.0b013e328357e4e5. No abstract available.

    PMID: 22955296DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research director

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 14, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

DK(1)