Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376064
• Other study ID #: CSMS995BDE16
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2006
• Last updated: March 2, 2017
• Start date: March 2006

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Octreotide acetate and cabergoline/Octrotide and Somavert

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)		8 months
Secondary	Effect of tumor size		8 months
Secondary	Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values		8 months
Secondary	Control clinical of symptoms of acromegaly		8 months
Secondary	Quality of Life assessment		8 months
Secondary	Safety and tolerability as assessed by frequency of AEs		8 months

External Links

•   Results for CSMS995BDE16 on the Novartis Clinical Trial Website