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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Chiasma, Inc.
Sponsor:
Information provided by (Responsible Party):
Chiasma, Inc.
ClinicalTrials.gov Identifier:
NCT02685709
First received: January 28, 2016
Last updated: March 2, 2017
Last verified: March 2017

January 28, 2016
March 2, 2017
February 2016
October 2018   (Final data collection date for primary outcome measure)
IGF-1 Time Weighted Average (TWA), during the RCT phase [ Time Frame: 62 weeks ]
Same as current
Complete list of historical versions of study NCT02685709 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Acromegaly
  • Drug: Octreotide capsules
    Octreotide capsules 40mg/day, 60mg/day, 80mg/day
  • Drug: Injectable Somatostatin Analogs (octreotide or lanreotide)
    Octreotide - 10, 20, 30mg. Lanreotide 60,90, 120mg.
  • Drug: Cabergoline
    Cabergoline - 3.5mg/week
  • Experimental: Run-in phase
    Oral octreotide capsules
    Intervention: Drug: Octreotide capsules
  • Experimental: RCT phase - Oral
    Oral octreotide capsules
    Intervention: Drug: Octreotide capsules
  • Active Comparator: RCT phase - Injectables
    Injectable somatostatin analogs (octreotide or lanreotide)
    Intervention: Drug: Injectable Somatostatin Analogs (octreotide or lanreotide)
  • Experimental: Combination phase (sub-study)
    Octreotide capsules plus cabergoline
    Interventions:
    • Drug: Octreotide capsules
    • Drug: Cabergoline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2019
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Engage Health +1-855-676-9733
United States,   Austria,   France,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Russian Federation,   Serbia,   Spain,   United Kingdom
 
 
NCT02685709
OOC-ACM-302
2015-002854-11 ( EudraCT Number )
Yes
Not Provided
Yes
Not Provided
Chiasma, Inc.
Chiasma, Inc.
Not Provided
Study Chair: Maria Fleseriu, M.D., FACE Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Chiasma, Inc.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP