Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly


Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)		Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00765323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
Original Secondary Outcome Measures ICMJE 

Descriptive Information

Brief Title  ICMJEEfficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Official Title  ICMJEPhase 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment
Condition  ICMJEAcromegaly
Intervention  ICMJE
  • Drug: Octreotide Implant
    84 mg octreotide implant (6 month implant)
    Other Name: somatostatin analogue
  • Drug: Sandostatin LAR Depot
    Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
    Other Name: somatostatin analogue
Study Arms / Comparison Groups
  • 1: Active Comparator
    84 mg octreotide implant
    Intervention: Drug: Octreotide Implant
  • 2: Active Comparator
    Injections of S-LAR
    Intervention: Drug: Sandostatin LAR Depot

Recruitment Information

Estimated Enrollment  ICMJE140
Estimated Completion DateDecember 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Endo Pharmaceuticals Solutions Inc., Senior Director Clinical R&D1-800-462-3636ClinicalTrials@endo.com
Location Countries  ICMJEUnited States,   Czech Republic,   Germany,   Hungary,   Poland,   Russian Federation,   Serbia,   Slovakia,   Spain

Administrative Information

NCT ID  ICMJENCT00765323
Responsible PartySenior Director Clinical R&D, Endo Pharmaceuticals Solutions Inc
Study ID Numbers  ICMJEIP107-001
Study Sponsor  ICMJEEndo Pharmaceuticals Solutions Inc.
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByEndo Pharmaceuticals Solutions Inc.