Phase III with Octreotide capsules in acromegaly patients
Research type
Research Study
Full title
A phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes in acromegaly patients treated with Octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands who previously tolerated and demonstrated a biochemical control of both treatments
IRAS ID
195534
Contact name
Professor Peter James Trainer
Contact email
Sponsor organisation
Chiasma, Inc.
Eudract number
2015-002854-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
5534, Clinical Research Network
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Acromegaly is a rare disease leading to disproportionate growth of mainly skeleton and organs. The enlargement of the bones and tissues is due to an over production of Growth Hormone (GH) and Insulin-like Growth Factor (IGF-1), which also causes cardiovascular, respiratory, hormonal and metabolic damages. For the large majority of patients, the disease is due to a benign tumour of the pituitary gland. Although surgery of the tumour and radiotherapy are current treatments, the injection of drugs such as octreotide and lanreotide (Synthetic Somatostatin drugs, SRLs, which supress GH over secretion in the majority of the patients) is the most widely standard of care used to control acromegaly. The development of octreotide capsules (investigational drug) as an oral treatment, would prevent the side-effects associated with chronic injection experienced by acromegaly patients.
The purpose of this study is to compare the effects between the standard of care by injection and the octreotide capsules on the stability of biochemical analysis, GH and IGF-1 levels and clinical symptoms (effectiveness), quality of life and outcomes on work activities and performance in acromegaly patients who were controlled and stable on both treatments.
The study consists of two phase treatments:
- the run-in phase where all the qualified patients will receive octreotide capsules twice a day for 26 weeks,
- and then the randomised phase where patients with well controlled level of GH and IGF-1 will be assigned for 36 additional weeks octreotide capsules or the standard of care by injection.The study could last approximately one year. At the end of this period if the disease is sufficiently controlled, patients will be able to continue with octreotide capsules until the capsules are commercially available or Sponsor terminates the study.
In total, there will be about 150 subjects participating in this study around the world including approximately 20 from the UK.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0219
Date of REC Opinion
20 May 2016
REC opinion
Further Information Favourable Opinion