Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients (HOSCAR)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01278342
First received: January 14, 2011
Last updated: April 20, 2011
Last verified: April 2011
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Purpose
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Sandostatin LAR Drug: pegvisomant Drug: cabergoline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen |
Resource links provided by NLM:
Drug Information available for:
Dopamine
Dopamine hydrochloride
Octreotide acetate
Cabergoline
Octreotide
Cabergoline diphosphate
Pegvisomant
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- The Percentage of Participants With Complete Response (CR) at 8 Months [ Time Frame: From Baseline to 8 months ] [ Designated as safety issue: No ]
A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
- Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
- IGF-I within the Central Laboratory Normal Range (for age and gender).
Secondary Outcome Measures:
- The Percentage of Participants With Complete Response (CR) At 3 Months [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
- Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
- IGF-I within the Central Laboratory Normal Range (for age and gender)
- The Percentage of Participants With Partial Response (PR) at 8 Months [ Time Frame: From Baseline to 8 months ] [ Designated as safety issue: No ]
Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
- Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.
- Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.
| Enrollment: | 70 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sandostatin LAR high dose Alone
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
|
Drug: Sandostatin LAR
40 mg intramuscular (i.m.) every 28 days for 3 months
Other Name: octreotide acetate
|
|
Experimental: Sandostatin LAR high dose + Pegvisomat
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months
|
Drug: Sandostatin LAR
40 mg intramuscular (i.m.) every 28 days for 3 months
Other Name: octreotide acetate
Drug: pegvisomant
Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months
Other Names:
|
|
Experimental: Sandostatin LAR high dose + Cabergoline
All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:
|
Drug: Sandostatin LAR
40 mg intramuscular (i.m.) every 28 days for 3 months
Other Name: octreotide acetate
Drug: cabergoline
Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows:
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)
- Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
- Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion
Exclusion Criteria:
- Newly diagnosed or previously medically untreated acromegalic patient
- Concomitant treatment with GH-receptor antagonist
- Concomitant treatment with dopamine-agonist
- Symptomatic cholelithiasis or choledocolithiasis
- Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)
- Previous gamma-knife radiotherapy for treatment of acromegaly
- Compression of the optic chiasm causing visual field defect
- Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278342
Locations
| France | |
| Novartis Investigative Site | |
| Brest Cedex, France, 29609 | |
| Novartis Investigative Site | |
| Bron Cedex, France, 69677 | |
| Novartis Investigative Site | |
| Kremlin-Bicetre, France, 94275 | |
| Novartis Investigative Site | |
| Nice, France, 06202 | |
| Novartis Investigative Site | |
| Nimes, France, 30029 | |
| Novartis Investigative Site | |
| Pessac, France, 33604 | |
| Novartis Investigative Site | |
| Toulouse, France, 31059 | |
| Italy | |
| Novartis Investigative Site | |
| Genova, Italy, 16132 | |
| Novarts Investigative Site | |
| Naples, Italy | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Novartis Investigative Site | |
| Padova, Italy | |
| Novartis Investigative Site | |
| Perugia, Italy, 06126 | |
| Novartis Investigative Site | |
| Pisa, Italy, 56124 | |
| Novartis Investigative Site | |
| Torino, Italy, 10126 | |
| Poland | |
| Novartis Investigative Site | |
| Lodz, Poland, 91-425 | |
| Novartis Investigative Site | |
| Warszawa, Poland | |
| Novartis Investigative Site | |
| Wroclaw, Poland | |
| Novartis Investigative Site | |
| Zabrze, Poland, 41-800 | |
| Portugal | |
| Novartis Investigative Site | |
| Porto, Portugal, 4200-319 | |
| Switzerland | |
| Novartis Investigative Site | |
| Lausanne, Switzerland, CH-1011 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01278342 History of Changes |
| Other Study ID Numbers: | CSMS995BIC03, 2005-005852-42 |
| Study First Received: | January 14, 2011 |
| Results First Received: | January 22, 2011 |
| Last Updated: | April 20, 2011 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Portugal: Health Ethic Committee Switzerland: Swissmedic Poland: Ministry of Health |
Keywords provided by Novartis:
|
Sandostatin LAR High Dose GH-receptor antagonist combination with dopamine-agonist acromegalic patients octreotide acetate |
Somavert Dostinex pegvisomant cabergoline not adequately controlled active acromegaly |
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 Dopamine Dopamine Agents Cabergoline Octreotide |
Dopamine Agonists Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013