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NCT00913055 Clinical Trial

Open Label Study of Octreotide Implant in Patients With Acromegaly

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00913055
Other study ID # 01-07-000
Secondary ID
Status Completed
Phase Phase 2
First received May 26, 2009
Last updated July 13, 2011
Start date February 2007
Est. completion date May 2007

Study information
Verified date July 2011
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics CommitteeBulgaria: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• octreotide acetate
subcutaneous implant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Endo Pharmaceuticals
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