4043 - REAL 2 NNC0195-0092 in adults with growth hormone deficiency

• Research type

  Research Study

• Full title

  A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency

• IRAS ID

  165031

• Contact name

  Andrew Toogood

• Contact email

  andrew.toogood@uhb.nhs.uk

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2014-000290-39

• Duration of Study in the UK

  0 years, 11 months, 19 days

• Research summary

  This study is designed to assess the safety of once weekly dosing with NNC0195-0092
  and daily dosing of Norditropin® FlexPro® in adults with growth hormone deficiency who have previously received growth hormone treatment for 26 weeks.

  The assignment of treatment for the NNC0195-0092 and Norditropin will be done in a randomised open labelled manner via an interactive voice response system (IVRS).

  This will be done in a 2:1 manner for NNC0195-0092:Norditropin.

  During the first 8 weeks of the trial titration of the patients' dose will take place. After the titration period patients will take a fixed dose of trial product.

  The primary endpoint for this study is the incidence of adverse events, including injection site reactions from baseline to the end of the treatment period (26 weeks).

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  14/WM/1218

• Date of REC Opinion

  26 Nov 2014

• REC opinion

  Favourable Opinion