Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Phase 4

Completed

• Conditions: Acromegaly
• Interventions: Drug: Octreotide acetate and cabergoline/Octrotide and Somavert

• Registration Number: NCT00376064
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Primary Completion: 2010-01
• Status Verified: 2011-09
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMS995 + Carbegolin, Somavert + SMS995	Octreotide acetate and cabergoline/Octrotide and Somavert	-

Primary Outcome Measures

Name	Time	Method
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)	8 months

Secondary Outcome Measures

Name	Time	Method
Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values	8 months
Control clinical of symptoms of acromegaly	8 months
Quality of Life assessment	8 months
Safety and tolerability as assessed by frequency of AEs	8 months
Effect of tumor size	8 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wurzburg, Germany