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Trial details imported from ClinicalTrials.gov

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Comparator / control treatment
Control group

Outcomes

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)

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
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02685709