Current partner codePEPTIDESDE
NCT00444873·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

38

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Mar 8, 2007

  2. Study start

    Jan 2005

  3. Primary completion

    Jan 2008

  4. Study completion

    Jan 2008

  5. Results posted

    Not reported

  6. Registry updated

    Nov 22, 2019

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

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)

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

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Klinikum Innenstadt

Munich, Germany

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

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