Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Brief Title

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Official Title

A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease

Brief Summary

      This study evaluated the safety and efficacy of an increased frequency of octreotide acetate
      injections or an increase in dose in partially responsive acromegalic patients with
      persistently uncontrolled disease.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)

Secondary Outcome

 Change in Tumor Volume From Screening to End of Study (Week 24)

Condition

Acromegaly

Intervention

Octreotide acetate 30 mg suspension

Study Arms / Comparison Groups

 Octreotide 30 mg every 21 days

Description:  Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.

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

28

Start Date

December 2005

Completion Date

October 2007

Primary Completion Date

October 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Written voluntary informed consent.

          -  Patients with biochemically documented active acromegaly who are currently receiving
             somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28
             days; lanreotide up to 120 mg/28 days) for at least 6 months.

          -  Patients with uncontrolled disease defined as patients with a decrease of baseline
             levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a
             conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28
             days) for at least 6 months.

          -  Baseline (mean of 3 samples) GH level > 2 µg/L.

          -  Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age
             and gender.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Novartis, , 

Location Countries

Italy

Location Countries

Italy

NCT ID

NCT00372697

Organization ID

CSMS995BIT12

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis, Study Chair, Novartis

Verification Date

April 2011