Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03252353




Registration number
NCT03252353
Ethics application status
Date submitted
10/08/2017
Date registered
17/08/2017

Titles & IDs
Public title
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
Secondary ID [1] 0 0
OOC-ACM-303
Universal Trial Number (UTN)
Trial acronym
OPTIMAL
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
Treatment: Drugs - Matching placebo

Active comparator: Octreotide capsules - Octreotide capsules

Placebo comparator: Matching Placebo - Matching placebo capsules


Treatment: Drugs: octreotide capsules
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)

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

Outcomes
Primary outcome [1] 0 0
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
Timepoint [1] 0 0
Week 36
Secondary outcome [2] 0 0
Number of Patients Who Begin Rescue Treatment
Timepoint [2] 0 0
Week 36

Eligibility
Key inclusion criteria
* Documented evidence of active acromegaly
* Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
* Biochemically controlled
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
* Pituitary surgery within six months
* Conventional or stereotactic pituitary radiotherapy any time in the past
* Patients who previously participated in CH-ACM-01 or OOC-ACM-302
* Any clinically significant uncontrolled concomitant disease
* Symptomatic cholelithiasis
* Pegvisomant, within 24 weeks
* Dopamine agonists, within 12 weeks
* Pasireotide, within 24 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Private Hospital-NSW - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Public Hospital - St Leonards
Recruitment hospital [3] 0 0
St Vincent's Hospital-VIC - Fitzroy
Recruitment hospital [4] 0 0
The Alfred - Melbourne
Recruitment hospital [5] 0 0
Melbourne Health - Parkville
Recruitment hospital [6] 0 0
Keogh Institute (Sir Charles Gardner) - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Denmark
State/province [18] 0 0
Aarhus
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Germany
State/province [20] 0 0
Aachen
Country [21] 0 0
Germany
State/province [21] 0 0
Munich
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Szeged
Country [24] 0 0
Israel
State/province [24] 0 0
Jerusalem
Country [25] 0 0
Israel
State/province [25] 0 0
Petah Tikva
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Italy
State/province [27] 0 0
Monserrato
Country [28] 0 0
Italy
State/province [28] 0 0
Pisa
Country [29] 0 0
Latvia
State/province [29] 0 0
Riga
Country [30] 0 0
Netherlands
State/province [30] 0 0
Leiden
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
New Zealand
State/province [32] 0 0
Dunedin
Country [33] 0 0
New Zealand
State/province [33] 0 0
Wellington
Country [34] 0 0
Poland
State/province [34] 0 0
Gdansk
Country [35] 0 0
Poland
State/province [35] 0 0
Katowice
Country [36] 0 0
Poland
State/province [36] 0 0
Krakow
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Poland
State/province [38] 0 0
Wroclaw
Country [39] 0 0
Slovenia
State/province [39] 0 0
Ljubljana
Country [40] 0 0
Sweden
State/province [40] 0 0
Göteborg
Country [41] 0 0
Turkey
State/province [41] 0 0
Ankara
Country [42] 0 0
Turkey
State/province [42] 0 0
Izmir
Country [43] 0 0
Turkey
State/province [43] 0 0
Kayseri
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Birmingham
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan L Samson, MD PhD
Address 0 0
Pituitary Center at Baylor St. Luke's Medical
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03252353