Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (OPTIMAL)
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|ClinicalTrials.gov Identifier: NCT03252353|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Results First Posted : October 19, 2020
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acromegaly||Drug: octreotide capsules Drug: Matching placebo||Phase 3|
This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.
This study received agreement from the FDA, under a special protocol assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official 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|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||June 13, 2019|
|Estimated Study Completion Date :||May 2022|
Active Comparator: Octreotide capsules
Drug: octreotide capsules
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
Other Name: MYCAPSSA
Placebo Comparator: Matching Placebo
Matching placebo capsules
Drug: Matching placebo
Matching placebo capsules
Other Name: Placebo
- Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. [ Time Frame: Week 36 ]Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is > 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values.
- Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period [ Time Frame: Week 36 ]Maintenance of GH response was defined as having mean Growth Hormone (5 measurements 30 minutes apart) < 2.5 ng/mL at the end of the double blind placebo controlled period, out of those who were responders on Somatostatin Receptor Ligands (SRLs) injections at Screening.
- Number of Patients Who Begin Rescue Treatment [ Time Frame: Week 36 ]Number of Patients who Began Rescue Treatment Prior to and Including Week 36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252353
|Study Chair:||Susan L Samson, MD PhD||Pituitary Center at Baylor St. Luke's Medical|