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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

January 14, 2008
January 28, 2015
February 2008
December 2010   (final data collection date for 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 ] [ 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".
Mean growth hormone (GH) level and insulin like growth factor-1 (IGF-1) level,12 months.
Complete list of historical versions of study NCT00600886 on ClinicalTrials.gov Archive Site
  • 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 ]
compare the effect of Pasireotide LAR and Octreotide LAR on change from baseline in mean growth hormone at 12 months of treatment
Not Provided
Not Provided
 
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acromegaly
  • Drug: Pasireotide
    SOM230 LAR
  • Drug: Octreotide
    Sandostatin LAR
    Other Name: Octrotide LAR
  • 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.
    Intervention: Drug: Pasireotide
  • 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.
    Intervention: Drug: Octreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
358
October 2015
December 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00600886
CSOM230C2305, 2007-001972-36
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
Novartis
January 2015

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