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

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. Read our disclaimer for details. Identifier: NCT02685709
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
Chiasma, Inc.

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Study Start Date : February 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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).

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02685709

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Sponsors and Collaborators
Chiasma, Inc.
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Study Chair: Maria Fleseriu, M.D., FACE Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Additional Information:
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Responsible Party: Chiasma, Inc. Identifier: NCT02685709    
Other Study ID Numbers: OOC-ACM-302
2015-002854-11 ( EudraCT Number )
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Chiasma, Inc.:
Octreotide Capsules
Additional relevant MeSH terms:
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Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
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