Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

NCT00145405 | Completed Phase 4

• 1 other identifier: 009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important. Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed. Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days. Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.

Conditions

Acromegaly

Keywords

Acromegaly; somatostatin analogues; lanreotide; octreotide; GH; IGF-I; injection site

Outcome Measures

Primary Outcomes (1)

• GH and IGF-I levels after 4, 6, 10, 12 months therapy.

Interventions

Lanreotide Autogel and Octreotide LAR DRUG

Eligibility Criteria

• Age: 22 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the patients which receive octreotide LAR can be included;
• New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated;

You may not qualify if:

• Which had not given their consent after they received standard information about the study;
• Current malign disease;
• Somatostatin analogues intolerance;
• Elevation of lever enzymes;
• Pregnancy.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Marianne Andersen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2002
• Study Completion: December 1, 2004
• Last Updated: September 8, 2006

Record last verified: 2005-09

Locations

DK (1)