Open Label Study of Octreotide Implant in Patients With Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Open Label Study of Octreotide Implant in Patients With Acromegaly

Official Title

An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly

Brief Summary

      To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and
      non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of
      treatment.

Detailed Description

      An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30
      male and female patients with acromegaly. Eligible patients received 1 implant, either
      hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was
      inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia.
      Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone
      (GH), and octreotide serum concentrations were collected at predetermined timepoints within
      the first 6 weeks after implantation.

Study Phase

Phase 2

Study Type

Interventional

Condition

Acromegaly

Intervention

octreotide acetate

Study Arms / Comparison Groups

 One hydrated 84mg Octreotide implant
Description:  hydrated implant

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

34

Start Date

February 2007

Completion Date

May 2007

Primary Completion Date

May 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female patients with acromegaly

          -  Must be at least 18 years old

          -  Confirmed diagnosis of a growth hormone -secreting tumor

          -  Must be either a full or partial responder to octreotide demonstrated by historical
             laboratory values

        Exclusion Criteria:

          -  Women who are pregnant, lactating or of child-bearing potential who are not practicing
             a medically acceptable method of birth control

          -  Patients with liver disease

          -  Patients with symptomatic cholelithiasis

          -  Patients receiving radiotherapy for their pituitary tumor at any time before Screening

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT00913055

Organization ID

01-07-000

Study Sponsor

Endo Pharmaceuticals

Study Sponsor

, ,

Verification Date

July 2011