NCT00216398

Brief Summary

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2006

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

September 13, 2005

Last Update Submit

August 14, 2019

Conditions

Acromegaly

Keywords

acromegalygrowth hormone

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary Outcomes (8)

  • The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.

  • The percentage of patients with normalised IGF-1 compared to the baseline visit.

  • Change in the GH values compared to the baseline (Week 0) visit.

  • Change in the IGF-1 values compared to the baseline (Week 0) visit.

  • Change in serum lanreotide levels compared to the baseline (Week 0) visit.

  • +3 more secondary outcomes

Interventions

Lanreotide (Autogel formulation)DRUG

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of acromegaly
  • The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L.
  • The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
  • Life expectancy of at least 2 years

You may not qualify if:

  • Adenectomy within past 6 months, or likely during study period
  • Radiotherapy for acromegalic disease within 1 year, or likely during study period
  • Unstable concomitant dopamine agonist therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ipsen Study Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

June 22, 2006

Study Completion

June 22, 2006

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

AU(1)