Open Label Study of Octreotide Implant in Patients With Acromegaly

NCT ID: NCT00913055

Last Updated: 2011-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-05-31

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.

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.

Conditions

Acromegaly

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One hydrated 84mg Octreotide implant

hydrated implant

Group Type: EXPERIMENTAL

octreotide acetate

Intervention Type: DRUG

subcutaneous implant

One non-hydrated 84mg Octreotide implant

Group Type: EXPERIMENTAL

octreotide acetate

Intervention Type: DRUG

subcutaneous implant

Interventions

octreotide acetate

subcutaneous implant

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals Solutions

Other Identifiers

01-07-000

Identifier Type: -

Identifier Source: org_study_id