Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

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Brief Title

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Official Title

An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

Brief Summary

      This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose
      monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone
      antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth
      factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at
      conventional regimen.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

The Percentage of Participants With Complete Response (CR) at 8 Months

Secondary Outcome

 The Percentage of Participants With Complete Response (CR) At 3 Months

Condition

Acromegaly

Intervention

Sandostatin LAR

Study Arms / Comparison Groups

 Sandostatin LAR high dose Alone
Description:  All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

70

Start Date

September 2006

Completion Date

November 2009

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria:

        • Patient with a biochemically documented active acromegaly, not adequately controlled by
        somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and
        elevated IGF-1 (adjusted for age and gender)

          -  Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25%
             from any medical pretreatment level

          -  Patient currently receiving somatostatin-analogues at conventional regimen (maximum
             registered dose) for at least 6 months before inclusion

        Exclusion Criteria:

          -  Newly diagnosed or previously medically untreated acromegalic patient

          -  Concomitant treatment with GH-receptor antagonist

          -  Concomitant treatment with dopamine-agonist

          -  Symptomatic cholelithiasis or choledocolithiasis

          -  Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according
             to local laboratory)

          -  Previous gamma-knife radiotherapy for treatment of acromegaly

          -  Compression of the optic chiasm causing visual field defect

          -  Any medical conditions contraindicated in the Summary of Product Characteristic (SPC)
             of all drugs

        Other protocol-defined inclusion/exclusion criteria may apply

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT01278342

Organization ID

CSMS995BIC03

Secondary IDs

2005-005852-42

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

February 2017