Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Launched by CHIASMA, INC. · Feb 14, 2016

Keywords

ClinConnect Summary

This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated biochemical control on both treatments.

The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase.

Eligible patients who were biochemically controlled on parenteral SRLs we...

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Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of acromegaly
• • Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
• • Biochemical control (IGF -1 \< 1.3 x ULN and GH \< 2.5ng/mL)
• Exclusion Criteria:
• • Injections of long-acting somatostatin analogs, at a dosing interval \> 8 weeks.
• • Pituitary radiotherapy within 5 years
• • Pituitary surgery within six months
• • Patients who previously participated in CH-ACM-01 study
• • Any clinically significant uncontrolled concomitant disease
• • Symptomatic cholelithiasis
• * Previous treatment with:
• • Pegvisomant, within 12 weeks
• • Dopamine agonists, within 6 weeks
• • Pasireotide, within 12 weeks