Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Brief Title

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Official Title

Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly

Brief Summary

      Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with
      acromegaly that were previously treated with octreotide depot.
    

Detailed Description

      This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1
      to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety
      will be determined from the Primary Treatment Phase. Eligible patients will be randomized
      during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label
      treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each
      patient in this study will return to the investigational center every 4 weeks; safety and
      efficacy assessments will be performed during these visits. All patients who complete the
      Primary Treatment Phase and who continue to meet eligibility criteria will be offered the
      opportunity to enter the Extension Phase; patients entering the Extension Phase will be
      treated with an octreotide implant for 6 months.During the Extension Phase, patients will
      return to the investigational center every 4 weeks; safety and efficacy assessments will be
      performed during these visits.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments

Condition

Acromegaly

Intervention

Octreotide Implant

Study Arms / Comparison Groups

 1

Description:  84 mg octreotide implant for 6 months

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

169

Start Date

September 2008

Completion Date

June 2011

Primary Completion Date

February 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female patients with acromegaly

          -  Confirmed diagnosis of a growth hormone-secreting tumor

          -  Received a stable dose of monthly octreotide depot injections for a minimum of 3
             consecutive months immediately prior to screening

          -  Must show a response to octreotide treatment with documented laboratory results at the
             screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age
             and sex-adjusted levels and GH ≤ 2.5 ng/mL

        Exclusion Criteria:

          -  Patients with pituitary surgery less than 3 months prior to screening

          -  Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%

          -  Symptomatic cholelithiasis

          -  Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening,
             or at any time during the trial

          -  Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any
             time before Screening
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Czech Republic

Location Countries

Czech Republic

NCT ID

NCT00765323

Organization ID

IP107-001

Responsible Party

Sponsor

Study Sponsor

Endo Pharmaceuticals

Study Sponsor

, , 

Verification Date

September 2013