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Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
This study is currently recruiting participants.
Verified by Novartis, May 2008
Sponsored by: Novartis
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
Phase IV

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Octreotide Octreotide acetate Somatotropin Somatropin Cabergoline Cabergoline diphosphate Somatostatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

Secondary Outcome Measures:
  • All assessed at baseline and EOS
  • Biochemical control (mean, normalization) as measured by GH- and IGF-1-values
  • Control of symptoms of acromegaly
  • Quality of Life assessment
  • Safety and tolerability as assessed by frequency of AEs

Estimated Enrollment: 100
Study Start Date: March 2006
  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 41 61 324 1111

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

Study ID Numbers: CSMS995BDE16
Study First Received: September 13, 2006
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00376064  
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

Study placed in the following topic categories:
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Octreotide
Brain Diseases
Bone Diseases
Somatostatin
Brain Neoplasms
Dopamine
Musculoskeletal Diseases
Endocrinopathy
Cabergoline
Adenoma
Acromegaly

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Gastrointestinal Agents
Antiparkinson Agents
Dopamine Agonists
Pharmacologic Actions
Hyperpituitarism
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009