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Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765323
Recruitment Status : Terminated
First Posted : October 2, 2008
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Octreotide Implant Drug: Sandostatin LAR Depot Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
84 mg octreotide implant for 6 months
Drug: Octreotide Implant
84 mg octreotide subcutaneous implant for 6 months
Other Name: somatostatin analogue

Active Comparator: 2
Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks
Drug: Sandostatin LAR Depot
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
Other Name: somatostatin analogue

Primary Outcome Measures :
  1. Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765323

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Sponsors and Collaborators
Endo Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Endo Pharmaceuticals Identifier: NCT00765323    
Other Study ID Numbers: IP107-001
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Keywords provided by Endo Pharmaceuticals:
Sandostatin LAR
Growth hormone
Additional relevant MeSH terms:
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Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs