NCT00171886

Brief Summary

Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function. This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

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

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 24, 2017

Status Verified

March 1, 2011

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

February 23, 2017

Conditions

Acromegaly

Keywords

AcromegalyOtreotideTumor reduction

Outcome Measures

Primary Outcomes (2)

  • To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated

    at baseline, weeks 12, 24, 48

  • To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated

    at baseline, weeks 12, 24, 48

Secondary Outcomes (2)

  • To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.

    at baseline, weeks 12, 24, 48

  • To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms

    at baseline, weeks 12, 24, 48

Study Arms (1)

octrotide

EXPERIMENTAL
Drug: Octreotide

Interventions

OctreotideDRUG
Also known as: SMS995
octrotide

Eligibility Criteria

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

You may qualify if:

  • Males and females 18 and \< 80 years old.
  • Recently diagnosed not previously treated patients with acromegaly.
  • Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
  • Absence of nadir suppression of the nadir of GH to \< 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
  • IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
  • Tolerance shown with a test of a subcutaneous injection of octreotide
  • Written Informed Consent before any procedure specific to the study. Inclus

You may not qualify if:

  • Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
  • Compression of optic chiasm that produces any impairment of field of vision.
  • Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
  • Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
  • Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
  • Pregnant women
  • Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative site

A Coruña, Spain

Location

Novartis Investigative site

Alicante, Spain

Location

Novartis Investigative site

Barcelona, Spain

Location

Novartis Investigative site

Burgos, Spain

Location

Novartis Investigative site

Córdoba, Spain

Location

Novartis Investigative site

Madrid, Spain

Location

Novartis Investigative site

Málaga, Spain

Location

Novartis Investigative site

Tarragona, Spain

Location

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 Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 24, 2017

Record last verified: 2011-03

Locations

ES(8)