Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Lanreotide Autogel and Octreotide LAR |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly |
- GH and IGF-I levels after 4, 6, 10, 12 months therapy.
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | December 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 22 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All the patients which receive octreotide LAR can be included;
- New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated;
- As long as they do not fit in the exclusion criteria.
Exclusion Criteria:
- 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.
Contacts and Locations| Denmark | |
| Department of Endocrinology, Odense University Hospital | |
| Odense, Funen, Denmark, 5000 | |
| Principal Investigator: | Marianne Andersen, MD, PhD | Odense University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00145405 History of Changes |
| Other Study ID Numbers: | 009 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 6, 2006 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Odense University Hospital:
|
Acromegaly somatostatin analogues lanreotide octreotide |
GH IGF-I injection site |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Octreotide Lanreotide Angiopeptin Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013