NCT00225979

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. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had 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

Timeline
Completed

Started Nov 2002

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

November 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

September 23, 2005

Last Update Submit

April 10, 2012

Conditions

Acromegaly

Keywords

AcromegalyUntreatedNewly diagnosedOctreotide LARPituitary surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • Tumor volume at baseline, week 24 and 48

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

  • Quality of life and sleep apnea at baseline, week 12, 24 and 48

  • Safety and tolerability at any time on treatment

Study Arms (1)

SMS995

EXPERIMENTAL
Drug: Octreotide LAR

Interventions

Octreotide LARDRUG
Also known as: SMS995
SMS995

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed or previously untreated acromegalic patients
  • Lack of suppression of GH nadir to \<1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
  • 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

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 26, 2005

Study Start

November 1, 2002

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

April 11, 2012

Record last verified: 2012-04