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Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376064
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Octreotide acetate and cabergoline/Octrotide and Somavert Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy
Study Start Date : March 2006
Actual Primary Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SMS995 + Carbegolin, Somavert + SMS995 Drug: Octreotide acetate and cabergoline/Octrotide and Somavert


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Effect of tumor size [ Time Frame: 8 months ]
  2. Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values [ Time Frame: 8 months ]
  3. Control clinical of symptoms of acromegaly [ Time Frame: 8 months ]
  4. Quality of Life assessment [ Time Frame: 8 months ]
  5. Safety and tolerability as assessed by frequency of AEs [ Time Frame: 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male and female patients (> 18 years) with prior surgery of micro- or macroadenoma of the pituitary.
  • At least 6 months chronic treatment with 30mg octreotide (long acting release).
  • Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used.
  • Lack of suppression of GH nadir to < 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
  • Patient's written informed consent.

Exclusion criteria:

  • Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
  • Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
  • Symptomatic cholelithiasis that is clinically relevant.
  • Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists.
  • Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376064


Locations
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Germany
Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Greifswald, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Koln, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Oldenburg, Germany
Novartis Investigative Site
Regensburg, Germany
Novartis Investigative Site
Tubingen, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Wurzburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00376064    
Other Study ID Numbers: CSMS995BDE16
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: September 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Growth hormone (GH)
IGF-1
Acromegaly
Pituitary adenoma
 Brain tumor
Brain cancer
Octreotide acetate
Additional relevant MeSH terms:
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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
 Cabergoline
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs