Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

NCT ID: NCT00376064

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

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

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMS995 + Carbegolin, Somavert + SMS995

Group Type: EXPERIMENTAL

Octreotide acetate and cabergoline/Octrotide and Somavert

Intervention Type: DRUG

Interventions

Octreotide acetate and cabergoline/Octrotide and Somavert

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

Novartis Investigative Site

Aachen, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Greifswald, , Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Marburg, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Oldenburg, , Germany

Novartis Investigative Site

Regensburg, , Germany

Novartis Investigative Site

Tübingen, , Germany

Novartis Investigative Site

Ulm, , Germany

Novartis Investigative Site

Würzburg, , Germany

Countries

Germany

Other Identifiers

CSMS995BDE16

Identifier Type: -

Identifier Source: org_study_id