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Completed

NCT Number: NCT01937702

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

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, 55116, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% NaCl (sodium chloride)

Other

Primary outcomes

  1. injection pain

    Time frame: within 24 hours after injection

Secondary outcomes

  1. variability of injection pain

    Time frame: within the first 24 hours after injection

Sponsors and collaborators

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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