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

• Sponsor: Profil Institut für Stoffwechselforschung GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01937702
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: 0.9% NaCl (sodium chloride)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. injection pain [within 24 hours after injection]

Secondary Outcome Measures

1. variability of injection pain [within the first 24 hours after injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Mainz GmbH & Co. KG	Mainz	Rheinland-Pfalz	Germany	55116

Sponsors and Collaborators

• Profil Institut für Stoffwechselforschung GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Profil Institut für Stoffwechselforschung GmbH
• ClinicalTrials.gov Identifier: NCT01937702
• Other Study ID Numbers: PSIP
• First Posted: Sep 9, 2013
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

Study Results

No Results Posted as of Dec 30, 2014