Efficacy and Safety of Octreolin for Acromegaly

• Research type

  Research Study

• Full title

  Efficacy and safety of oral Octreolin™ in patients with acromegaly who are currently receiving parenteral somatostatin analogs

• IRAS ID

  86317

• Contact name

  Marta Korbonits

• Sponsor organisation

  Medpace UK

• Eudract number

  2011-002912-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Acromegaly is a rare disease causing bone, tissue and organ growth. This is due to the over production of growth hormones (GH) and insulin-like growth factors (IGF-1). The high levels of these hormones leads to a wide range of associated diseases affecting the heart and lungs, the levels of hormones released directly into the bloodstream and the metabolism. In many cases the reason for Acromegaly is due to a tumour on the pituitary gland, in the brain.Many of the current treatments of Acromegaly involve the use of injectable medicines called Somatostatin analogs (SSTa). This study aims to assess the safety and the effectiveness of a new formulation of one of these treatments - octreotide. This new formulation will allow people who suffer from acromegaly to swallow their medication instead of injecting it, this cannot be done at present since the acids present in the stomach prevent enough medicine being absorbed to make it an effective treatment for Acromegaly. This has been accomplished by using an enteric coated capsule filled with an oily suspension of octreotide formulated with a chemical called a transient permeability enhancer (TPE) - this complex formulation allows the medicine to pass through the stomach to the small intestine where the capsule disintegrates and the medicine is then absorbed. Based on results from 4 previous clinical trials where Octreolin has been given to 73 healthy female and male volunteers, Octreolin was safe and well-tolerated in all subjects. The side effects seen were similar to those for the Sandostatin (approved SSTa) control arms and to that reported for octreotide.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0320

• Date of REC Opinion

  11 Oct 2011

• REC opinion

  Further Information Favourable Opinion