We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label Study of Octreotide Implant in Patients With Acromegaly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913055
First Posted: June 3, 2009
Last Update Posted: July 14, 2011
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.
Information provided by:
Endo Pharmaceuticals
  Purpose
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 Intervention Phase
Acromegaly Drug: octreotide acetate Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Enrollment: 34
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Responsible Party: Mark Roessel, Endo Pharmaceuticals Solutions
ClinicalTrials.gov Identifier: NCT00913055     History of Changes
Other Study ID Numbers: 01-07-000
First Submitted: May 26, 2009
First Posted: June 3, 2009
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Endo Pharmaceuticals:
S-LAR
Octreotide
Implant

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
Dimenhydrinate
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action