Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
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ClinicalTrials.gov Identifier: NCT00376064 |
Recruitment Status :
Completed
First Posted : September 14, 2006
Last Update Posted : March 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Octreotide acetate and cabergoline/Octrotide and Somavert | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: SMS995 + Carbegolin, Somavert + SMS995 |
Drug: Octreotide acetate and cabergoline/Octrotide and Somavert |
- Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) [ Time Frame: 8 months ]
- Effect of tumor size [ Time Frame: 8 months ]
- Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values [ Time Frame: 8 months ]
- Control clinical of symptoms of acromegaly [ Time Frame: 8 months ]
- Quality of Life assessment [ Time Frame: 8 months ]
- Safety and tolerability as assessed by frequency of AEs [ Time Frame: 8 months ]

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

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
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
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 |
Growth hormone (GH) IGF-1 Acromegaly Pituitary adenoma |
Brain tumor Brain cancer Octreotide acetate |
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 |