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Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly (MPOWERED)

This study is currently recruiting participants.
Verified September 2017 by Chiasma, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02685709
First Posted: February 19, 2016
Last Update Posted: September 25, 2017
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiasma, Inc.
  Purpose

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.


Condition Intervention Phase
Acromegaly Drug: Octreotide capsules Drug: Injectable Somatostatin Analogs (octreotide or lanreotide) Drug: Cabergoline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Chiasma, Inc.:

Primary Outcome Measures:
  • IGF-1 Time Weighted Average (TWA), during the RCT phase [ Time Frame: 62 weeks ]

Secondary Outcome Measures:
  • Change in acromegaly symptoms [ Time Frame: 62 weeks ]
    Acromegaly Index of Severity Score (AIS) - Headache, Swelling of extremities, Joint pain, Sweating and Fatigue, assessed by severity (0-3).

  • Proportion of patients with clinical and biochemical response [ Time Frame: 62 weeks ]
    Biochemical response - IGF-1 TWA Clinical response - maintained or improved acromegaly symptoms

  • Patient reported outcomes [ Time Frame: 62 weeks ]
    Acro-TSQ - newly developed and validated patient reported outcome questionnaire


Estimated Enrollment: 150
Study Start Date: February 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Run-in phase
Oral octreotide capsules
Drug: Octreotide capsules
Octreotide capsules 40mg/day, 60mg/day, 80mg/day
Experimental: RCT phase - Oral
Oral octreotide capsules
Drug: Octreotide capsules
Octreotide capsules 40mg/day, 60mg/day, 80mg/day
Active Comparator: RCT phase - Injectables
Injectable somatostatin analogs (octreotide or lanreotide)
Drug: Injectable Somatostatin Analogs (octreotide or lanreotide)
Octreotide - 10, 20, 30mg. Lanreotide 60,90, 120mg.
Experimental: Combination phase (sub-study)
Octreotide capsules plus cabergoline
Drug: Octreotide capsules
Octreotide capsules 40mg/day, 60mg/day, 80mg/day
Drug: Cabergoline
Cabergoline - 3.5mg/week

Detailed Description:

This will be a phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with SOC parenteral SRLs, who previously tolerated and demonstrated biochemical control on both treatments.

The core study will consist of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment Phase (RCT).

Eligible patients who are biochemically controlled on parenteral SRLs will be switched to octreotide capsules for a 26-week Run-in phase. During this phase the effective dose for each patient will be determined through dose titration.

Patients whose acromegaly is been controlled biochemically on octreotide capsules at the end of the Run-in Phase will enter a 36-week open-label Randomized Controlled Treatment Phase, where they will be 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 will be offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination.

A Sub-study, in selected sites, would allow patients with in-adequate 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02685709


Contacts
Contact: Engage Health +1-855-676-9733

  Show 54 Study Locations
Sponsors and Collaborators
Chiasma, Inc.
Investigators
Study Chair: Maria Fleseriu, M.D., FACE Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
  More Information

Additional Information:
Publications:
Responsible Party: Chiasma, Inc.
ClinicalTrials.gov Identifier: NCT02685709     History of Changes
Other Study ID Numbers: OOC-ACM-302
2015-002854-11 ( EudraCT Number )
First Submitted: January 28, 2016
First Posted: February 19, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Chiasma, Inc.:
Octreotide Capsules
Acromegaly
Somatostatin
Mpowered
OOC-ACM-302

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Angiopeptin
Cabergoline
Somatostatin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action