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Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly (PAOLA)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 27, 2010
Last updated: November 4, 2014
Last verified: November 2014

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Condition Intervention Phase
Drug: Pasireotide (SOM230)
Drug: octreotide LAR 30mg
Drug: lanreotide ATG 120mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measure the tumor volume reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the IGF-1 level alone at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the overall safety and tolerability of Pasireotide LAR 40 mg and pasireotide LAR 60 mg [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Measure the health-related quality of life using the AcroQoL instrument [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR 40 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Drug: Pasireotide (SOM230)
  • Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
  • Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
Experimental: Pasireotide LAR 60 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Drug: Pasireotide (SOM230)
  • Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
  • Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
Active Comparator: Control arm (octreotide or lanreotide)

If a patient is randomized to the open label arm the investigator will either:

  • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or
  • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
Drug: octreotide LAR 30mg
In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
Drug: lanreotide ATG 120mg
In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization


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

Inclusion Criteria:

  1. Patients with written informed consent prior to any study related activity
  2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
  3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg
  4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

  1. Patients who have received pasireotide (SOM 230) prior to enrolment
  2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
  3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects
  4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
  5. Patients who have received pituitary irradiation within 10 years prior to visit 1 (screening).
  6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
  7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

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 identifier: NCT01137682

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United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90073
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21229
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
University of Texas Southwestern Medical Center Division of Hematology/Oncolog
Dallas, Texas, United States, 75235
United States, Washington
Swedish Neuroscience Institute 550 17th Avenue, Suite 500
Seattle, Washington, United States, 98122
Novartis Investigative Site
Buenos Aires, Argentina, C1405BCH
Novartis Investigative Site
Brussels, Belgium, BE-B-1200
Novartis Investigative Site
Edegem, Belgium, 2650
Novartis Investigative Site
Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Fortaleza, CE, Brazil, 60430-370
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Sao Luis, MA, Brazil, 65020-070
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Rio de Janeiro, RJ, Brazil, 21941-913
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Joinville, SC, Brazil, 89201260
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Botucatu, SP, Brazil, 18618-970
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Campinas, SP, Brazil, 13083-970
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Sao Paulo, SP, Brazil, 05403-000
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São Paulo, SP, Brazil, 04038-002
Canada, Quebec
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1H 5N4
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Bogota, Cundinamarca, Colombia, 111411
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Bogotá, Colombia, 00000
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Cali, Colombia
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Bron, France, 69677
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Dijon, France, 21034
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Le Kremlin Bicetre, France, 94275
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Lille, France, 59037
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Marseille, France, 13005
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Pessac Cedex, France, 33604
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Rennes Cedex, France, 35022
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St Herblain - Nantes, France, 44093
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Toulouse Cedex 9, France, 31000
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Erlangen, Germany, 91054
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Hamburg, Germany, 22559
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Muenchen, Germany, 80336
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Würzburg, Germany, 97080
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Petach Tikva, Israel, 49100
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Genova, GE, Italy, 16132
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Messina, ME, Italy, 98125
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Roma, RM, Italy, 00168
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Torino, TO, Italy, 10126
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Napoli, Italy, 80131
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Bergen, Norway, NO-5021
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Oslo, Norway, NO-0379
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Gdansk, Poland, 80-952
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Poznan, Poland, 60-355
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Wroclaw, Poland, 50-367
Novartis Investigative Site
Bucuresti, Romania, 011863
Russian Federation
Novartis Investigative Site
Barnaul, Russian Federation, 656024
Novartis Investigative Site
Moscow, Russian Federation, 117036
Novartis Investigative Site
Moscow, Russian Federation, 119992
Novartis Investigative Site
Tyumen, Russian Federation, 625023
Saudi Arabia
Novartis Investigative Site
Jeddah, Saudi Arabia, 21423
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Riyadh, Saudi Arabia, 11211
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Sevilla, Andalucia, Spain, 41013
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Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03010
Novartis Investigative Site
Madrid, Spain, 28006
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Antalya, Turkey, 07070
Novartis Investigative Site
Izmir, Turkey, 35340
United Kingdom
Novartis Investigative Site
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01137682     History of Changes
Other Study ID Numbers: CSOM230C2402, 2009-016722-13, EUDRACT 2009-016722-13
Study First Received: May 27, 2010
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Colombia: Institutional Review Board
France: Ministry of Health
Germany: Ministry of Health
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Spain: Ministry of Health and Consumption
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Mexico: Ministry of Health

Keywords provided by Novartis:
hormone disorder
growth hormone
insulin like growth factor-1
pituitary tumor

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2014