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Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00765323
First received: September 30, 2008
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Acromegaly
 Drug: Octreotide Implant
Drug: Sandostatin LAR Depot
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
84 mg octreotide implant
 Drug: Octreotide Implant
84 mg octreotide implant (6 month implant)
Other Name: somatostatin analogue
Active Comparator: 2
Injections of S-LAR
 Drug: Sandostatin LAR Depot
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
Other Name: somatostatin analogue

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765323

  Show 44 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Senior Director Clinical R&D, Endo Pharmaceuticals Solutions Inc
ClinicalTrials.gov Identifier: NCT00765323     History of Changes
Other Study ID Numbers: IP107-001
Study First Received: September 30, 2008
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Octreotide
Sandostatin LAR
Growth hormone
IGF-1

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
 Octreotide
Somatostatin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013