Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00376064
First received: September 13, 2006
Last updated: September 22, 2011
Last verified: September 2011
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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 ]

Enrollment: 20
Study Start Date: March 2006
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS995 + Carbegolin, Somavert + SMS995 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

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00376064     History of Changes
Other Study ID Numbers: CSMS995BDE16
Study First Received: September 13, 2006
Last Updated: September 22, 2011
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:
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014