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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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Acromegaly

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IP107-001

NCT ID:

NCT00765323

Start Date:

September 2008

Completion Date:

June 2011

Related Keywords:

  • Acromegaly
  • Octreotide
  • Sandostatin LAR
  • Growth hormone
  • IGF-1
  • Acromegaly

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Seattle, Washington  98195
Denver, Colorado  
Baltimore, Maryland  21287
Eugene, Oregon