AcromegalyPhase 4POTANCT00521300
Preoperative Octreotide Treatment of Acromegaly
A Phase 4 study testing Octreotide and Direct surgery for acromegaly in people with Acromegaly, run by St. Olavs Hospital at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Octreotide and Direct surgery for acromegaly
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesNorway
- Study dates
- Sep 1999to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
- Pituitary tumor by MRI-scan.
Who cannot join
- Immediate surgery indicated by usual clinical criteria.
- Pregnant.
- Known adverse effects of octreotide.
- Unfit for participation by any other reason.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
Bergen
Endocrinology Unit, Department of Medicine, Aker University Hospital
Oslo
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
Oslo
Endocrinology Unit, Department of Medicine, University Hospital of North Norway
Tromsø
Department of Endocrinology, St. Olavs Hospital
Trondheim, 7006
About this study
Official title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
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.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- Octreotide, Direct surgery for acromegaly
- Keywords
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called Sandostatin, Sandostatin LAR
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
Direct surgery for acromegalyProcedure or surgery
Direct transsphenoidal surgery
| Study group | Role | What they receive |
|---|---|---|
| octreotide | Experimental | 6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly Receives: Drug: Octreotide |
| standard surgery | Active comparator | Standard transphenoidal surgery soon after the diagnosis of acromegaly Receives: Procedure: Direct surgery for acromegaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical cure by transsphenoidal surgery
Measured: Primarily 3 months postoperatively, but up to 10 years postoperatively
Secondary outcomes (1)
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
Measured: Primarily 3 months postoperatively, but up to 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startSep 1999
- Primary completionJun 2005
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Sven M Carlsen, MD, PhD, Principal investigator, Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521300
- Sponsor's protocol ID
- S-71-98 (REK)
- Other IDs
- S-71-98, SLKNR 98-5560
- Acronym
- POTA
- Status last verified
- May 2014
- First submitted
- 24 Aug 2007
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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 patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab. 2008 Aug;93(8):2984-90. doi: 10.1210/jc.2008-0315. Epub 2008 May 20.
PubMed 18492760Carlsen 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, tumour volume, and postoperative cure. Clin Endocrinol (Oxf). 2011 Jun;74(6):736-43. doi: 10.1111/j.1365-2265.2011.03982.x.
PubMed 21521254Fougner SL, Bollerslev J, Svartberg J, Oksnes 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 27.
PubMed 24866574Olarescu NC, Ueland T, Godang K, Lindberg-Larsen R, Jorgensen JO, Bollerslev J. Inflammatory adipokines contribute to insulin resistance in active acromegaly and respond differently to different treatment modalities. Eur J Endocrinol. 2013 Nov 22;170(1):39-48. doi: 10.1530/EJE-13-0523. Print 2014 Jan.
PubMed 24092547
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT00521300
- Acronym / sponsor ID
- POTA / S-71-98 (REK)
- Conditions
- Acromegaly
- Keywords
- Acromegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 1999
- Primary completion
- Jun 2005 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| octreotide | Experimental | Drug: Octreotide6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly |
| standard surgery | Active comparator | Procedure: Direct surgery for acromegalyStandard transphenoidal surgery soon after the diagnosis of acromegaly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
- Pituitary tumor by MRI-scan.
Key exclusion criteria (4 listed)
- Immediate surgery indicated by usual clinical criteria.
- Pregnant.
- Known adverse effects of octreotide.
- Unfit for participation by any other reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctreotideAlso: Sandostatin, Sandostatin LARFirst 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 | Drug | octreotide |
| Direct surgery for acromegalyDirect transsphenoidal surgery | Procedure or surgery | standard surgery |
Primary outcome
Surgical cure by transsphenoidal surgery
Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively
1 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
Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Results publication: PubMed 18492760Carlsen 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 patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab. 2008 Aug;93(8):2984-90. doi: 10.1210/jc.2008-0315. Epub 2008 May 20.
- Results publication: PubMed 21521254Carlsen 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, tumour volume, and postoperative cure. Clin Endocrinol (Oxf). 2011 Jun;74(6):736-43. doi: 10.1111/j.1365-2265.2011.03982.x.
- Results publication: PubMed 24866574Fougner SL, Bollerslev J, Svartberg J, Oksnes 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 27.
- Derived from this study: PubMed 24092547Olarescu NC, Ueland T, Godang K, Lindberg-Larsen R, Jorgensen JO, Bollerslev J. Inflammatory adipokines contribute to insulin resistance in active acromegaly and respond differently to different treatment modalities. Eur J Endocrinol. 2013 Nov 22;170(1):39-48. doi: 10.1530/EJE-13-0523. Print 2014 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven M Carlsen, MD, PhD principal investigator
Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octreotide and Direct surgery for acromegaly in people with Acromegaly, run by St. Olavs Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical cure by transsphenoidal surgery (time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521300, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.