Open Label Study of Octreotide Implant in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00913055
First received: May 26, 2009
Last updated: July 13, 2011
Last verified: July 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mark Roessel, Endo Pharmaceuticals Solutions
ClinicalTrials.gov Identifier: NCT00913055     History of Changes
Other Study ID Numbers: 01-07-000
Study First Received: May 26, 2009
Last Updated: July 13, 2011
Health Authority: Russia: Ethics Committee
Bulgaria: Ministry of Health
United States: Food and Drug Administration

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
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014