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

NCT ID: NCT01937702

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anti-diabetes medication

Insulin

Group Type EXPERIMENTAL

0.9% NaCl (sodium chloride)

Intervention Type OTHER

Interventions

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0.9% NaCl (sodium chloride)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Forst, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Mainz GmbH & Co KG

Locations

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Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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PSIP

Identifier Type: -

Identifier Source: org_study_id