Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Brief Title

Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Official Title

Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Brief Summary

      Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma
      causing overproduction of growth hormone which leads to acromegaly. The objective of this
      study is to assess the safety and efficacy of long-acting repeatable formulation of
      octreotide and to compare it to the safety and efficacy of surgery in patients with
      acromegaly who have not had any previous treatment for acromegaly.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary Outcome

 Tumor volume at baseline, week 24 and 48

Condition

Acromegaly

Intervention

Octreotide LAR

Study Arms / Comparison Groups

 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 Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

November 2002

Completion Date

March 2005

Primary Completion Date

March 2005

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed or previously untreated acromegalic patients

          -  Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of
             glucose (OGTT)

          -  IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age
             and gender)

        Exclusion Criteria:

          -  Requires surgery for recent significant deterioration in visual fields or other
             neurological signs, which are related to the pituitary tumor mass

          -  No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)

          -  Symptomatic cholelithiasis

        Other protocol-defined exclusion criteria may apply.

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, ,

Administrative Informations

NCT ID

NCT00225979

Organization ID

CSMS995B2402

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

April 2012