NCT00444873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

March 7, 2007

Last Update Submit

November 21, 2019

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 intervalDRUG

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

28 day dose interval42 day dose interval56 day dose interval

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 21086246RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotideDuration of Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth 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)