Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Brief Title

Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

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

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
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

Secondary Outcome

 Effect of tumor size

Condition

Acromegaly

Intervention

Octreotide acetate and cabergoline/Octrotide and Somavert

Study Arms / Comparison Groups

 SMS995 + Carbegolin, Somavert + SMS995

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

March 2006

Primary Completion Date

January 2010

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.

        Other protocol-defined inclusion/exclusion criteria may apply
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT00376064

Organization ID

CSMS995BDE16

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmeceuticals

Verification Date

September 2011