NPSP 558 in Adults with Hypoparathyroidism (NPS 040)

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism

• IRAS ID

  9369

• Contact name

  William D Fraser

• Sponsor organisation

  NPS Pharmaceuticals, Inc

• Eudract number

  2008-005063-34

• Clinicaltrials.gov Identifier

  NCT00732615

• Research summary

  This is a phase 3 placebo-controlled study funded by NPS pharmaceuticals which will be testing a compound called NPSP 558. The purpose of this study is to find out how safe and effective NPSP 558 is in treating adults with hypoparathyroidism. Hypoparathyroidism is the abnormally low production of parathyroid hormone from the parathyroid glands and results in low calcium levels in the body. Patients in this study will be randomly (like flipping a coin) placed into 1 of 2 treatment groups. One group will receive NPSP 558 while the other group will receive a placebo (Ó?dummy? drug). Two out of every three patients will be placed in the group that receives NPSP 558 and one will be placed in the placebo group. The study aims to randomise 110 male and female patients. Patients will be required to self-administer the treatment using an injection pen device and treatment should be taken once a day for 24 weeks. Patients will be required to give blood and urine samples and keep a trial record diary during the study. It is hoped that NPSP 558 will help to normalise calcium levels in the body and reduce the need for patients to take oral calcium and Vitamin D supplements.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/92

• Date of REC Opinion

  4 Aug 2009

• REC opinion

  Further Information Favourable Opinion