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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02685709




Registration number
NCT02685709
Ethics application status
Date submitted
28/01/2016
Date registered
19/02/2016
Date last updated
22/04/2022

Titles & IDs
Public title
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Scientific title
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
Secondary ID [1] 0 0
2015-002854-11
Secondary ID [2] 0 0
OOC-ACM-302
Universal Trial Number (UTN)
Trial acronym
MPOWERED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Octreotide capsules

Experimental: Run-in phase - Oral octreotide capsules

Experimental: RCT phase - Oral - Oral octreotide capsules

Active Comparator: RCT phase - Injectables - Injectable somatostatin analogs (octreotide or lanreotide)

Experimental: Combination phase (sub-study) - Octreotide capsules plus cabergoline


Treatment: Drugs: Octreotide capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
Timepoint [1] 0 0
62 weeks
Secondary outcome [1] 0 0
Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
Timepoint [1] 0 0
Week 62/ End of treatment; EOT
Secondary outcome [2] 0 0
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
Timepoint [2] 0 0
62 weeks
Secondary outcome [3] 0 0
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
Timepoint [3] 0 0
62 weeks
Secondary outcome [4] 0 0
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
Timepoint [4] 0 0
62 weeks
Secondary outcome [5] 0 0
Change in IGF-1 Levels in the RCT Phase
Timepoint [5] 0 0
Change from Week 26 to week 62
Secondary outcome [6] 0 0
Change in GH Levels in the RCT Phase
Timepoint [6] 0 0
Change from Week 26 to week 62

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2021
Sample size
Target
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Austria
State/province [14] 0 0
Graz
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
France
State/province [16] 0 0
Bron
Country [17] 0 0
France
State/province [17] 0 0
Le Kremlin-Bicêtre
Country [18] 0 0
Germany
State/province [18] 0 0
Oldenburg
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Hungary
State/province [20] 0 0
Pecs
Country [21] 0 0
Hungary
State/province [21] 0 0
Szeged
Country [22] 0 0
Italy
State/province [22] 0 0
Monserrato
Country [23] 0 0
Italy
State/province [23] 0 0
Pisa
Country [24] 0 0
Italy
State/province [24] 0 0
Rome
Country [25] 0 0
Lithuania
State/province [25] 0 0
Kaunas
Country [26] 0 0
Lithuania
State/province [26] 0 0
Vilnius
Country [27] 0 0
Poland
State/province [27] 0 0
Gdansk
Country [28] 0 0
Poland
State/province [28] 0 0
Wroclaw
Country [29] 0 0
Romania
State/province [29] 0 0
Bucharest
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Barnaul
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Kazan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Krasnoyarsk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Novosibirsk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Saint-Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Samara
Country [37] 0 0
Serbia
State/province [37] 0 0
Belgrade
Country [38] 0 0
Spain
State/province [38] 0 0
Alzira
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Santiago de Compostela
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Birmingham
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Manchester
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Newcastle upon Tyne
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chiasma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02685709
Trial related presentations / publications
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. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Maria Fleseriu, M.D., FACE
Address 0 0
Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries