NCT00913055

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

3 months

First QC Date

May 26, 2009

Last Update Submit

July 13, 2011

Conditions

Acromegaly

Keywords

S-LAROctreotideImplant

Study Arms (2)

One hydrated 84mg Octreotide implant

EXPERIMENTAL

hydrated implant

Drug: octreotide acetate

One non-hydrated 84mg Octreotide implant

EXPERIMENTAL
Drug: octreotide acetate

Interventions

octreotide acetateDRUG

subcutaneous implant

One hydrated 84mg Octreotide implantOne non-hydrated 84mg Octreotide implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2009

First Posted

June 3, 2009

Study Start

February 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 14, 2011

Record last verified: 2011-07