NCT00128232

Brief Summary

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

August 8, 2005

Last Update Submit

April 27, 2012

Conditions

Acromegaly

Keywords

Acromegalyuntreatednewly diagnosedoctreotide LAR

Outcome Measures

Primary Outcomes (1)

  • Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary Outcomes (3)

  • Tumor volume at baseline, week 24 and 48

  • Signs and symptoms of acromegaly at baseline, week 12, 24 and 48

  • Safety and tolerability at any time on treatment

Interventions

Octreotide LARDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed or previously untreated acromegalic patients
  • Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\])
  • Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

You may not qualify if:

  • Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
  • No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
  • Symptomatic cholelithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephan Petersenn, MD

    Universität Duisburg-Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

December 1, 2002

Primary Completion

August 1, 2004

Last Updated

April 30, 2012

Record last verified: 2012-04