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Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
This study is currently recruiting participants.
Verified by Novartis, November 2009
First Received: September 13, 2006   Last Updated: November 18, 2009   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00376064
  Purpose

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 Intervention Phase
Acromegaly
Drug: Octreotide acetate and cabergoline/Octrotide and Somavert
Phase IV

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of tumor size [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Control clinical of symptoms of acromegaly [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Quality of Life assessment [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Safety and tolerability as assessed by frequency of AEs [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SMS995 + Carbegolin, Somavert + SMS995: Experimental Drug: Octreotide acetate and cabergoline/Octrotide and Somavert

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376064

Contacts
Contact: Novartis Pharmaceuticals 800-340-6843

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

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CSMS995BDE16
Study First Received: September 13, 2006
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00376064     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Growth hormone (GH)
IGF-1
Acromegaly
Pituitary adenoma
Brain tumor
Brain cancer
Octreotide acetate

Additional relevant MeSH terms:
Pituitary Diseases
Bone Diseases, Endocrine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Octreotide
Antiparkinson Agents
Brain Diseases
Dopamine Agonists
Bone Diseases
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly
Hypothalamic Diseases
Antineoplastic Agents, Hormonal
Nervous System Diseases
Gastrointestinal Agents
Endocrine System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Dopamine Agents
Cabergoline
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010