Octreotide Efficacy and Safety in First-line Acromegalic Patients
This study has suspended participant recruitment.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171886
First received: September 13, 2005
Last updated: March 23, 2011
Last verified: March 2011
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Purpose
Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.
This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Octreotide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Octreotide Efficacy and Safety in First-line Acromegalic Patients |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]
- To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life. [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]
- To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | July 2002 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: octrotide |
Drug: Octreotide
Other Name: SMS995
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females 18 and < 80 years old.
- Recently diagnosed not previously treated patients with acromegaly.
- Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
- Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
- IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
- Tolerance shown with a test of a subcutaneous injection of octreotide
- Written Informed Consent before any procedure specific to the study. Inclus
Exclusion Criteria:
- Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
- Compression of optic chiasm that produces any impairment of field of vision.
- Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
- Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
- Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
- Pregnant women
- History of alcohol or drug abuse in the six months prior to the inclusion visit.
- Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
- Intake of an investigational drug during the study and 30 days before patient inclusion in this study
Other protocol-defined inclusion / exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171886
Locations
| Spain | |
| Novartis Investigative site | |
| Alicante, Spain | |
| Novartis Investigative site | |
| Barcelona, Spain | |
| Novartis Investigative site | |
| Burgos, Spain | |
| Novartis Investigative site | |
| Cordoba, Spain | |
| Novartis Investigative site | |
| Coruna, Spain | |
| Novartis Investigative site | |
| Madrid, Spain | |
| Novartis Investigative site | |
| Malaga, Spain | |
| Novartis Investigative site | |
| Tarragona, Spain | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00171886 History of Changes |
| Other Study ID Numbers: | CSMS995BES02 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 23, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
Acromegaly Otreotide Tumor reduction |
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 Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013