Non Interventional Post Marketing Programme in Acromegaly
Summary
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Conditions
Acromegaly
Location
Aberdeen Royal Infirmary
Aberdeen
United Kingdom
AB25 2ZN
Status
Completed
Source
Ipsen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00747500
- Information obtained from ClinicalTrials.gov on May 21, 2013
Medical and Biotech [MESH] Definitions
Macroglossia
The presence of an excessively large tongue, which may be congenital or may develop as a result of a tumor or edema due to obstruction of lymphatic vessels, or it may occur in association with hyperpituitarism or acromegaly. It also may be associated with malocclusion because of pressure of the tongue on the teeth. (From Jablonski, Dictionary of Dentistry, 1992)
Growth Hormone-secreting Pituitary Adenoma
A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.
Acromegaly
A condition caused by prolonged exposure to excessive HUMAN GROWTH HORMONE in adults. It is characterized by bony enlargement of the FACE; lower jaw (PROGNATHISM); hands; FEET; HEAD; and THORAX. The most common etiology is a GROWTH HORMONE-SECRETING PITUITARY ADENOMA. (From Joynt, Clinical Neurology, 1992, Ch36, pp79-80)
Adenoma, Acidophil
A benign tumor, usually found in the anterior lobe of the pituitary gland, whose cells stain with acid dyes. Such pituitary tumors may give rise to excessive secretion of growth hormone, resulting in gigantism or acromegaly. A specific type of acidophil adenoma may give rise to nonpuerperal galactorrhea. (Dorland, 27th ed)
Sleep Apnea, Obstructive
A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395)
Clinical Trials
Preoperative Octreotide Treatment of Acromegaly
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.
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved...
Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly
Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatme...
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess the lon...
Preoperative Octreotide Treatment of Patients With Acromegaly
Surgery is the primary treatment of acromegaly. However, it often fails to cure the patient. The objective was to investigate whether 6-month preoperative treatment with octreotide improve...
PubMed Articles
OBJECTIVE: The aim of this work was to retrospectively study the long-term reliability of the common consensus endocrinological criteria for the assessment of postoperative remission of acromegaly. PA...
Prevalence of cerebral aneurysm in patients with acromegaly.
The prevalence of cerebral aneurysm was retrospectively investigated in 208 patients with acromegaly relative to the rate of cerebral aneurysm in a group of control subjects. Neuroradiological examina...
Estrogen treatment for acromegaly.
Estrogens have been used in patients with acromegaly since the 1930-1940s, suppressing plasma IGF-1 levels and improving clinical signs and symptoms of acromegaly. Estrogens antagonize GH function at...
What is active acromegaly and which parameters do we have?
Disease activity of acromegaly can be measured in many ways. Growth hormone (GH) and insulin-like growth factor 1 (IGF1) concentrations are the main biochemical markers used to measure the response to...
Colonic neoplasia in acromegaly: increased proliferation or deceased apoptosis?
Patients with acromegaly have higher prevalence of colorectal neoplasms. The pathogenetic mechanism is still unclear and may be related to sustained increase in serum GH-IGF1. We aimed to evaluate the...
