Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs

Status Completed

Clinical Trial Summary

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).

Clinical Trial Description

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 were switched to octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose for each patient was determined through dose titration. Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening). Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination. A Sub-study, performed in selected non-European sites, allowed patients with inadequate biochemical control on octreotide capsules during the Run-in phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks. ;

Study Design

Related Conditions & MeSH terms

Acromegaly

Clinical Trial Details

NCT number	NCT02685709
Study type	Interventional
Source	Chiasma, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	February 2016
Completion date	August 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06344650` - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting	`NCT02092129` - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.	N/A
Completed	`NCT02012127` - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting	`NCT01265121` - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.	N/A
Terminated	`NCT00765323` - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly	Phase 3
Completed	`NCT00531908` - Physiopathology of Sodium Retention in Acromegaly	N/A
Completed	`NCT00500227` - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed	`NCT01278342` - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients	Phase 4
Active, not recruiting	`NCT01809808` - A Prospective Study of Outcome After Therapy for Acromegaly
Completed	`NCT00145405` - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction	Phase 4
Completed	`NCT00210457` - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients	Phase 3
Recruiting	`NCT05401084` - Diet in the Management of Acromegaly	N/A
Recruiting	`NCT00005100` - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly	N/A
Completed	`NCT00521300` - Preoperative Octreotide Treatment of Acromegaly	Phase 4
Completed	`NCT03548415` - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands	Phase 2
Not yet recruiting	`NCT04066569` - Reproducibility and Utility of OGTT in Acromegaly	N/A
Not yet recruiting	`NCT05298891` - Hypoproteic Diet in Acromegaly	N/A
Recruiting	`NCT04520646` - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy	N/A
Not yet recruiting	`NCT04529356` - The TMS Treatment for Postoperative Headache in GH Tumor	N/A
Active, not recruiting	`NCT03252353` - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly — MPOWERED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms