NCT01937702

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

August 27, 2013

Last Update Submit

December 29, 2014

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • injection pain

    within 24 hours after injection

Secondary Outcomes (1)

  • variability of injection pain

    within the first 24 hours after injection

Study Arms (1)

Anti-diabetes medication

EXPERIMENTAL

Insulin

Other: 0.9% NaCl (sodium chloride)

Interventions

0.9% NaCl (sodium chloride)OTHER
Anti-diabetes medication

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has signed the informed consent form prior to screening
  • Age 18-74 years at screening (both included)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas Forst, Prof, MD

    Profil Mainz GmbH & Co KG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 9, 2013

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

DE(1)