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Open Label 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.
 
ClinicalTrials.gov Identifier: NCT00913055
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : July 14, 2011
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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Brief Summary:
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: octreotide acetate Phase 2

Detailed Description:
An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30 male and female patients with acromegaly. Eligible patients received 1 implant, either hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone (GH), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly
Study Start Date : February 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: One hydrated 84mg Octreotide implant
hydrated implant
 Drug: octreotide acetate
subcutaneous implant
Experimental: One non-hydrated 84mg Octreotide implant Drug: octreotide acetate
subcutaneous implant


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with acromegaly
  • Must be at least 18 years old
  • Confirmed diagnosis of a growth hormone -secreting tumor
  • Must be either a full or partial responder to octreotide demonstrated by historical laboratory values

Exclusion Criteria:

  • Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control
  • Patients with liver disease
  • Patients with symptomatic cholelithiasis
  • Patients receiving radiotherapy for their pituitary tumor at any time before Screening
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Mark Roessel, Endo Pharmaceuticals Solutions
ClinicalTrials.gov Identifier: NCT00913055    
Other Study ID Numbers: 01-07-000
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011
Keywords provided by Endo Pharmaceuticals:
S-LAR
Octreotide
Implant
Additional relevant MeSH terms:
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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
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents