Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600886
First received: January 14, 2008
Last updated: January 28, 2015
Last verified: January 2015
  Purpose

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.


Condition Intervention Phase
Acromegaly
Drug: Pasireotide
Drug: Octreotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    "Post Surgery" were participants who underwent surgery and their data were collected post surgery. Remaining participant, who were not suitable for or refused surgery, were considered "De novo".


Secondary Outcome Measures:
  • Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: February 2008
Estimated Study Completion Date: October 2015
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR
Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR ) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator. Dose could be down- or up-titrated to 20 or 60 mg, respectively.
Drug: Pasireotide
SOM230 LAR
Active Comparator: Octreotide LAR
Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
Drug: Octreotide
Sandostatin LAR
Other Name: Octrotide LAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with active acromegaly (based on elevated GH and IGF-1 levels)
  • Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
  • Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

  • Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
  • Patients with compression of the optic chiasm causing any visual field defect
  • Patients who have received pituitary irradiation within the last ten years prior to visit 1
  • Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600886

  Show 95 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600886     History of Changes
Other Study ID Numbers: CSOM230C2305, 2007-001972-36
Study First Received: January 14, 2008
Results First Received: December 19, 2014
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Canada: Food Inspection Agency
China: Ministry of Health
Colombia: Institutional Review Board
Czech Republic: Ministry of Health
Denmark: Ministry of Health
France: Ministry of Health
Greece: Ministry of Health and Welfare
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Korea, Republic of: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sports
Norway: Norwegian Medicines Agency
Poland: Ministry of Health and Social Security
Portugal: Ministry of Health
Russia: Ministry of Public health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Turkey: Ministry of Health
Taiwan: Department of Health
United Kingdom: Health Protection Agency
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Acromegaly,
adult,
growth hormone,
insulin-like growth factor I,
somatostatin analogue

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 07, 2015