Trial record 3 of 42 for:    safety and efficacy of pasireotide

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 15, 2013
Last verified: January 2013

January 14, 2008
January 15, 2013
February 2008
December 2010   (final data collection date for primary outcome measure)
Mean growth hormone (GH) level and insulin like growth factor-1 (IGF-1) level,12 months. [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
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 and octreotide LAR on tumor volume at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on normalization of IGF-1 at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on the reduction of mean GH level AND normalization of IGF-1 at month 6 and 9 [ Time Frame: At 6 months & at 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on health related quality of life at 12 months [ Time Frame: At 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: SOM230 LAR @ 40mg
    SOM230 LAR @ 40mg
    Intervention: Drug: Pasireotide
  • Active Comparator: Octreotide LAR @ 20 mg
    Octreotide LAR @ 20 mg
    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
533
June 2014
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,   Portugal,   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 2013

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