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:
Novartis Pharmaceuticals
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
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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:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 533 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | June 2014 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SOM230 LAR @ 40mg
SOM230 LAR @ 40mg
|
Drug: Pasireotide
SOM230 LAR
|
|
Active Comparator: Octreotide LAR @ 20 mg
Octreotide LAR @ 20 mg
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600886
Show 98 Study Locations
Show 98 Study LocationsSponsors 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 |
| Last Updated: | January 15, 2013 |
| 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, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013