Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00444873
Other study ID # A-94-52030-163
Secondary ID 2004-001435-33
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2005
Est. completion date January 2008

Study information

Verified date November 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Klinikum Innenstadt Munich

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plöckinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel® 120 mg at different dose intervals in patients with acromegaly previously — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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)
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06344650 - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting NCT02092129 - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly. N/A
Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3