Preoperative Octreotide Treatment of Patients With Acromegaly

This study is ongoing, but not recruiting participants.

First Received: October 14, 2005 Last Updated: September 6, 2007 History of Changes

Sponsors and Collaborators:	Novartis Norwegian Neuroendocrine Interest Group
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241033

Purpose

The purpose of this study is to assess if pretreatment with a somatostatin ligand receptor might reduce tumor volume and facilitate surgical procedure and outcome

Condition	Intervention	Phase
Patients With Acromegaly	Drug: octreotide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Octreotide Treatment of Patients With Acromegaly

Resource links provided by NLM:

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Primary outcome
Cure rate 3 months postoperative evaluated by IGF-1 levels and HGH nadir during OGTT
Cure defined as
HGH ≤ 2 or 5 mIU/L during OGTT
IGF-1 ≤ local upper referance value

Secondary Outcome Measures:

No secondary outcomes/objectives planned

Estimated Enrollment:	64
Study Start Date:	September 1999

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Increased level of growth-hormone, not possible to suppress below 5 IE/l after use of standard oral 75 g glucoseinduction
Diagnosed pituitary micro/macroadom with MR
Age 18 - 80

Exclusion Criteria

Emergency surgery needed
Pregnancy
MR- contraindication
Hypersensitivity against octreotide

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241033

Locations

Norway

Trondheim, Norway

Sponsors and Collaborators

Novartis

Norwegian Neuroendocrine Interest Group

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CSMS995 NO01
Study First Received:	October 14, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00241033 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Antineoplastic Agents, Hormonal
Pituitary Diseases
Musculoskeletal Diseases
Octreotide

Endocrine System Diseases
Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Endocrine System Diseases

Octreotide
Brain Diseases
Bone Diseases
Pharmacologic Actions
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly

ClinicalTrials.gov processed this record on September 10, 2009