Open Label Study of Octreotide Implant in Patients With Acromegaly

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Dimenhydrinate; Octreotide

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