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NCT01937702 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01937702
Other study ID # PSIP
Secondary ID
Status Completed
Phase Phase 1
First received August 27, 2013
Last updated December 29, 2014
Start date April 2014
Est. completion date September 2014

Study information
Verified date December 2014
Source Profil Institut für Stoffwechselforschung GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• 0.9% NaCl (sodium chloride)

Locations
Country Name City State
Germany Profil Mainz GmbH & Co. KG Mainz Rheinland-Pfalz

Sponsors (1)
Lead Sponsor Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary injection pain within 24 hours after injection No
Secondary variability of injection pain within the first 24 hours after injection No
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