Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00444873
First received: March 7, 2007
Last updated: June 18, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels. [ Time Frame: 1 dose interval after the last administration of Lanreotide Autogel 120mg ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels. [ Time Frame: Last three injections of Lanreotiude Autogel 120mg ] [ Designated as safety issue: No ]
- Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels [ Time Frame: Interval between doses after titration in part 2 of treatment (injections 3-6) ] [ Designated as safety issue: No ]
- Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment. [ Time Frame: 1 dose interval after the last administration of Lanreotide Autogel 120mg ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | January 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 28 day dose interval |
Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
| Experimental: 42 day dose interval |
Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
| Experimental: 56 day dose interval |
Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
Detailed Description:
Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) > 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment
Exclusion Criteria:
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
- The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry
Contacts and Locations More Information
Publications:
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00444873 History of Changes |
| Other Study ID Numbers: | A-94-52030-163 |
| Study First Received: | March 7, 2007 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ipsen:
|
Inappropriate Growth Hormone Secretion Syndrome (Acromegaly) |
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 Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013