An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly

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Brief Title

An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

Official Title

Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

Brief Summary

      Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth
      hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the
      long-term safety and efficacy of pasireotide in participants with acromegaly.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class

Secondary Outcome

 Time to Tumor Response

Condition

Acromegaly

Intervention

Pasireotide

Study Arms / Comparison Groups

 Pasireotide s.c. Overall
Description:  Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (μg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 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

30

Start Date

August 24, 2004

Completion Date

December 6, 2013

Primary Completion Date

December 6, 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Participants who have completed all four treatment regimens in the core study
             CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and
             insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide
             administration at any of the three doses.

          -  Participants who did not experience any unacceptable adverse events or tolerability
             issues during the core study CSOM230B2201.

        Exclusion Criteria:

          -  Participants who experienced or developed compression of the optic chiasm causing any
             visual field defect during the core study CSOM230B2201.

          -  Participants who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression during the core study CSOM230B2201.

          -  Participants who experienced or developed congestive heart failure, unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation or acute myocardial
             infraction during the core study CSOM230B2201.

        Other protocol-defined inclusion/exclusion criteria may apply.

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00171730

Organization ID

CSOM230B2201E1

Secondary IDs

2004-002849-12

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

September 2021