Expired Study
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Los Angeles, California 90095


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.


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


Study is Available At:


Original ID:

CSOM230C2305


NCT ID:

NCT00600886


Secondary ID:

2007-001972-36


Study Acronym:


Brief Title:

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


Official Title:

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

358


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:February 2008
Completion Date:October 2015
Completion Type:Anticipated
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 28, 2015
First Received Date:January 14, 2008
First Results Date:December 19, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life
Time Frame:12 Months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume
Time Frame:12 Months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone
Time Frame:12 Months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:"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".

Study Interventions

Intervention Type:Drug
Name:Pasireotide
Description:SOM230 LAR
Arm Name:Pasireotide LAR
Intervention Type:Drug
Name:Octreotide
Description:Sandostatin LAR
Arm Name:Octreotide LAR
Other Name:Octrotide LAR

Study Arms

Study Arm Type:Experimental
Arm Name:Pasireotide LAR
Description: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.
Study Arm Type:Active Comparator
Arm Name:Octreotide LAR
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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