A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain

Overview

A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2014

Interventions

  • Other: 0.9% NaCl (sodium chloride)

Arms, Groups and Cohorts

  • Experimental: Anti-diabetes medication
    • Insulin

Clinical Trial Outcome Measures

Primary Measures

  • injection pain
    • Time Frame: within 24 hours after injection

Secondary Measures

  • variability of injection pain
    • Time Frame: within the first 24 hours after injection

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has signed the informed consent form prior to screening – Age 18-74 years at screening (both included) Exclusion Criteria:

  • Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit – Previous participation in this trial. Participation is defined as having received at least one injection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Profil Institut für Stoffwechselforschung GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Forst, Prof, MD, Principal Investigator, Profil Mainz GmbH & Co KG

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