CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Genotropin Pen +3 moredevice
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/NCT01112865
NCT01112865Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.

Pfizer·interventional·Posted Apr 28, 2010·Updated May 22, 2012

In Brief

A Phase 3 clinical trial evaluating Genotropin Pen and MARK VII pen for Growth Hormone Deficiency. Completed, enrolled 120 participants across 23 sites in 7 countries.

Detailed Summary

Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency
CountriesCzechia, Germany, Netherlands, Slovakia, Sweden, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.2 years ago

Interventions

Genotropin Pendevice

Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.

MARK VII pendevice

Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.

Genotropin Pendevice

Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.

MARK VII pendevice

Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.