Preoperative Octreotide Treatment of Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Preoperative Octreotide Treatment of Acromegaly

Official Title

Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Brief Summary

      The purpose of this study is to investigate whether 6 months preoperative treatment with the
      somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.

Detailed Description

      After a baseline evaluation, patients are randomized separately for each study center in
      blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with
      octreotide.

      To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide
      is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three
      times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR
      (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months.
      Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are
      delayed, an extra octreotide LAR injection is given before surgery.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Surgical cure by transsphenoidal surgery

Secondary Outcome

 Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly

Condition

Acromegaly

Intervention

Octreotide

Study Arms / Comparison Groups

 octreotide
Description:  6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

62

Start Date

September 1999

Completion Date

May 2010

Primary Completion Date

June 2005

Eligibility Criteria

        Inclusion Criteria:

          -  GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.

          -  Pituitary tumor by MRI-scan.

        Exclusion Criteria:

          -  Immediate surgery indicated by usual clinical criteria.

          -  Pregnant.

          -  Known adverse effects of octreotide.

          -  Unfit for participation by any other reason.

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sven M Carlsen, MD, PhD, ,

Location Countries

Norway

Location Countries

Norway

Administrative Informations

NCT ID

NCT00521300

Organization ID

S-71-98 (REK)

Secondary IDs

S-71-98

Responsible Party

Sponsor

Study Sponsor

St. Olavs Hospital

Collaborators

 Novartis

Study Sponsor

Sven M Carlsen, MD, PhD, Principal Investigator, Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway

Verification Date

May 2014