Preoperative Octreotide Treatment of Acromegaly

Acromegaly Clinical Trial

— POTA  

Official title:

Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521300
• Other study ID #: S-71-98 (REK)
• Secondary ID: S-71-98SLKNR 98-
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2007
• Last updated: May 30, 2014
• Start date: September 1999
• Est. completion date: May 2010

Study information

• Verified date: May 2014
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00241033

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2010
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly
• Growth Hormone-Secreting Pituitary Adenoma

Intervention

Drug:
• Octreotide
First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months

Procedure:
• Direct surgery for acromegaly
Direct transsphenoidal surgery

Locations

Country	Name	City	State
Norway	Endocrinology Unit, Department of Medicine, Haukeland University Hospital	Bergen
Norway	Endocrinology Unit, Department of Medicine, Aker University Hospital	Oslo
Norway	Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center	Oslo
Norway	Endocrinology Unit, Department of Medicine, University Hospital of North Norway	Tromsø
Norway	Department of Endocrinology, St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Novartis

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Carlsen SM, Lund-Johansen M, Schreiner T, Aanderud S, Johannesen O, Svartberg J, Cooper JG, Hald JK, Fougner SL, Bollerslev J; Preoperative Octreotide Treatment of Acromegaly study group. Preoperative octreotide treatment in newly diagnosed acromegalic pa — View Citation

Carlsen SM, Svartberg J, Schreiner T, Aanderud S, Johannesen O, Skeie S, Lund-Johansen M, Fougner SL, Bollerslev J; POTA study group. Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumo — View Citation

Fougner SL, Bollerslev J, Svartberg J, Øksnes M, Cooper J, Carlsen SM. Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial. Eur J Endocrinol. 2014 Aug;171(2):229-35. doi: 10.1530/EJE-14-0249. Epub 2014 May 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical cure by transsphenoidal surgery		Primarily 3 months postoperatively, but up to 10 years postoperatively	No
Secondary	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		Primarily 3 months postoperatively, but up to 10 years postoperatively	No