A Trial Investigating the Influence of Injection Speed an... | NCT01937702

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

NCT01937702

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

80Actual

Phase

Phase 1

Conditions

Diabetes Mellitus

Interventions

0.9% NaCl (sodium chloride)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Sep 4, 2013

First Posted Date

Sep 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti-diabetes medication	Experimental	Insulin	Other: 0.9% NaCl (sodium chloride)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.9% NaCl (sodium chloride)	Other		Anti-diabetes medication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
injection pain		within 24 hours after injection

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Forst, Prof, MD	Profil Mainz GmbH & Co KG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Profil Mainz GmbH & Co. KG		Mainz	Rhineland-Palatinate	55116	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided