CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 82 enrolled
Drug / intervention
sodium chloride 0.9% solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680328
NCT01680328Phase 1Completed
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Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations

Novo Nordisk A/S·interventional·Posted Sep 7, 2012·Updated Mar 3, 2017

In Brief

A Phase 1 clinical trial evaluating 19 injections and sodium chloride 0.9% solution for Diabetes and 3 related conditions. Completed, enrolled 82 participants across 1 site.

Detailed Summary

This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartAug 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

19 injectionsother

Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).

sodium chloride 0.9% solutiondrug

Solution for injection.