ClinicalTrials.gg
Sign In
CompletedNCT00791024Updated Aug 26, 2015

Development of a New Method for Analgesia

A Phase 1/2 interventional study of CRC-Pharma 001 and lidocaine suspension in Analgesia, sponsored by Ove Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-08-26.

Sponsored by Ove Andersen · Phase 1/2, Interventional, and Supportive care

Phase
Phase 1/2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Analgesia

Keywords

  • Analgesia Tests
  • Analog Pain Scale
  • Pain Measurement
03

In context

Lead sponsor

Ove Andersen is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe psychiatric diseases
  • Alcohol abuse
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    single arm

    Drug: CRC-Pharma 001 · Drug: lidocaine suspension

Interventions

  • DrugCRC-Pharma 001

    50 mg

  • Druglidocaine suspension

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

06

What researchers measure

Primary outcomes

  1. VAS score

    Time frame: at day O and 3

Secondary outcomes

  1. Questionnaire( examiner and patient)

    Time frame: performed at day 0 and 3

07

Study locations

1 site
  • Copenhagen University, Hvidovre Hospital
    Hvidovre, 2650, Denmark
08

References and documents

Publications

  • 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. PubMed 22955296 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00791024
Lead sponsor
Ove Andersen
Collaborators
University of Copenhagen
Responsible party
Ove Andersen (Research director, Hvidovre University Hospital) — Sponsor-investigator
First posted
Nov 14, 2008
Start date
Nov 2008
Primary completion
Nov 2009
Completion
Jan 2010
Last update
Aug 26, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lidocaine

Other studies in this condition

Agnosia

Other studies from this sponsor

Ove Andersen

Start the discussion