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

December 29, 2014 updated by: Profil Institut für Stoffwechselforschung GmbH
A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • Profil Mainz GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anti-diabetes medication
Insulin
Other: 0.9% NaCl (sodium chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
injection pain
Time Frame: within 24 hours after injection
within 24 hours after injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Investigators

  • Principal Investigator: Thomas Forst, Prof, MD, Profil Mainz GmbH & Co KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PSIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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