The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (ACROINNOVA 1)

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.
 
ClinicalTrials.gov Identifier: NCT04076462
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Camurus AB

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: CAM2029 (octreotide subcutaneous depot) Drug: Matching placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
Actual Study Start Date : August 19, 2019
Actual Primary Completion Date : May 2, 2023
Actual Study Completion Date : May 2, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CAM2029 (octreotide subcutaneous depot)
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
 Drug: CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Other Name: CAM2029
Placebo Comparator: Matching placebo
Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
 Drug: Matching placebo
Matching placebo for CAM2029
Other Name: placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of patients with mean IGF-1 levels ≤1xULN [ Time Frame: Week 22 and 24 ]

Secondary Outcome Measures :
  1. Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction [ Time Frame: Week 22 and 24 ]
  2. Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24 [ Time Frame: Week 22 and 24 ]
  3. Proportion of patients with mean GH levels <2.5 µg/L [ Time Frame: Week 24 ]
  4. Proportion of patients with mean GH levels <1.0 µg/L [ Time Frame: Week 24 ]
  5. Incidence of treatment emergent adverse events [ Time Frame: Week 0 to 24 ]
  6. Proportion of patients/partners declared competent by a healthcare professional to administer intervention [ Time Frame: Week 0 to 20 and week 24 ]
    During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place

  7. Octreotide plasma concentrations over time [ Time Frame: Week 0 to 24 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, ≥18 years at screening
  • Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
  • Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
  • IGF-1 levels ≤1xULN at screening
  • Adequate liver, pancreatic, renal and bone marrow functions
  • Normal ECG

Exclusion Criteria:

  • GH ≥2.5 μg/L at screening (cycle)
  • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]
  • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
  • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
  • Patients who have undergone pituitary surgery within 6 months prior to screening
  • Patients who have received prior pituitary irradiation
  • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04076462


Locations
Show Show 63 study locations
Sponsors and Collaborators
Camurus AB
Investigators
Layout table for investigator information
Principal Investigator: Pamela Freda, M.D Columbia University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT04076462    
Other Study ID Numbers: HS-18-633
2019-001191-11 ( EudraCT Number )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camurus AB:
Acromegaly
octreotide
CAM2029
phase 3
Additional relevant MeSH terms:
Layout table for 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
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents