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The effect of pre-operative Octreotide LAR treatment on surgical cure rates of subjects with Acromegaly, and post-operative responsiveness to somatostatin analogue treatment in patients not cured surgically. - Pre-operative Octreotide LAR for Acromegaly

The effect of pre-operative Octreotide LAR treatment on surgical cure rates of subjects with Acromegaly, and post-operative responsiveness to somatostatin analogue treatment in patients not cured surgically. - Pre-operative Octreotide LAR for Acromegaly

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003496-20-GB
Enrollment
30
Registered
2006-10-16
Start date
2006-10-31
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly, overproduction of growth hormone by (almost always) a benign pituitary tumour.

Interventions

Product Name: Sandostatin LAR 20mg Pharmaceutical Form: Suspension for injection INN or Proposed INN: Octreotide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-

Sponsors

Oxford Radcliffe Hospitals NHS trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Acromegaly undergoing pituitary surgery in Oxford Macroadenoma (pituitary tumour >1cm in size on MRI) Age 16-85 Not taking concomittant somatostatin analogue therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Microadenoma Previous surgery or radiotherapy Age 200UMOL/L) Known Cardiac conduction disease History of Pancreatitis Pregnancy Breast Feeding

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine whether pre-treatment with Octreotide LAR improves surgical cure rates for subjects with Acromegaly due to a large pituitary tumour (pituitary macroadenoma).;Secondary Objective: To determine whether surgery affects the degree of suppression of Growth Hormone achieved by Octreotide pre- and post-operatively.;Primary end point(s): 15 patients in each arm (treatment vs controls).—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026