DRUG
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Status
Completed
Phase
Phase 3
Enrollment
146
Locations
53
Results
Posted
Publications
3
Study summary
What the protocol is testing.
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).
Full detailed 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 19, 2016
Study start
Feb 2016
Primary completion
Oct 2020
Study completion
Aug 2021
Results posted
Apr 22, 2022
Registry updated
Apr 22, 2022
Outcomes
What the study measures.
Primary outcomes
Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
Time frame · 62 weeks
Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is \<1.3 ULN
Secondary outcomes
Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
Time frame · Week 62/ End of treatment; EOT
Proportion of patients with clinical and biochemical control at the end of the RCT phase. Patients were considered biochemically and clinically controlled if they met both of the following criteria: * Their IGF-1 TWA during the RCT phase was \<1.3 times ULN * Their AIS score at week 62/EOT was maintained or reduced compared to week 26 (start of RCT phase)
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
Time frame · 62 weeks
Proportion of patients who maintain or reduce the overall number of active acromegaly symptoms at the end of the RCT phase (week 62/ EOT) , compared to week 26 (start of the RCT phase
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
Time frame · 62 weeks
Proportion of patients who maintain or improve their overall Acromegaly index of severity (AIS) score at the end of the RCT phase (improvement defined as a reduction of at least one point in the AIS score), compared to week 26 (start of the RCT phase)
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
Time frame · 62 weeks
Proportion of patients of those completing the RCT phase (at a time octreotide capsules were not commercially available at the specific country), who entered the Study Extension phase, overall and by treatment group
Change in IGF-1 Levels in the RCT Phase
Time frame · Change from Week 26 to week 62
Change in IGF-1 levels from the start of the randomized phase to the end of RCT phase. Complete Responder (CR) is defined as IGF-1 ≤ 1 x ULN; Partial Responder (PR) is defined as 1 x ULN \< IGF-1 \< 1.3 x ULN, and Non-Responder (NR): IGF-1 ≥ 1.3 x ULN
Change in GH Levels in the RCT Phase
Time frame · Change from Week 26 to week 62
Change in GH levels from the start of the randomized phase through the end of RCT phase.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
53 registered sites.
Austria · France · Germany · Hungary · Italy · Lithuania · Poland · Romania · Russia · Serbia · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Keck Medical Center of University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie
Graz, Austria
Medizinische Universität Wien
Vienna, Austria
Hospices Civils de Lyon
Bron, France
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
Praxis für Endokrinologie und Diabetologie Dr M Droste
Oldenburg, Germany
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
Publications
Results and literature.
PMID 25664604 ↗Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9.PMID 26610414 ↗Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.PMID 34953531 ↗Fleseriu M, Dreval A, Bondar I, Vagapova G, Macut D, Pokramovich YG, Molitch ME, Leonova N, Raverot G, Grineva E, Poteshkin YE, Gilgun-Sherki Y, Ludlam WH, Patou G, Haviv A, Gordon MB, Biermasz NR, Melmed S, Strasburger CJ. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2022 Feb;10(2):102-111. doi: 10.1016/S2213-8587(21)00296-5. Epub 2021 Dec 22.
Related trials
More studies on Lanreotide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Camurus AB · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
332
2026-07
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Crinetics Pharmaceuticals Inc. · Carcinoid Syndrome · Carcinoid
Phase 3
Recruiting
141
2026-06
Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study
West China Hospital · Neuroendocrine Tumors
Not applicable
Active, not recruiting
500
2026-04
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
National Health Research Institutes, Taiwan · Neuroendocrine Tumors,Gastroenteropancreatic
Phase 1 / Phase 2
Recruiting
49
2026-04
Lanreotide In Polycystic Kidney Disease Study
Assistance Publique - Hôpitaux de Paris · Autosomal Dominant Polycystic Kidney Disease (ADPKD
Phase 3
Completed
159
2026-04
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
SWOG Cancer Research Network · Pancreatic Carcinoma · Pancreatic Neoplasm
Phase 3
Recruiting
274
2026-03
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
RayzeBio, Inc. · GEP-NET · Gastroenteropancreatic Neuroendocrine Tumor
Phase 3
Recruiting
338
2026-03
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Crinetics Pharmaceuticals Inc. · Carcinoid Syndrome · Carcinoid
Phase 2
Completed
36
2026-03
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.