Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

NCT00444873 | Completed Phase 3

• 2 other identifiers: A-94-52030-1632004-001435-33
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acromegaly

Keywords

Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 dose interval after the last administration of Lanreotide Autogel 120mg

Secondary Outcomes (3)

• 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.

  Last three injections of Lanreotiude Autogel 120mg

• 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

  Interval between doses after titration in part 2 of treatment (injections 3-6)

• Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.

  1 dose interval after the last administration of Lanreotide Autogel 120mg

Study Arms (3)

28 day dose interval

EXPERIMENTAL

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

42 day dose interval

EXPERIMENTAL

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

56 day dose interval

EXPERIMENTAL

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

Interventions

lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval DRUG

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

28 day dose interval; 42 day dose interval; 56 day dose interval

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Klinikum Innenstadt

Munich, 80336, Germany

Location

Related Publications (1)

• Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plockinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel(R) 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17.

  PMID: 21086246 RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide; Duration of Therapy

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: January 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

DE (1)