Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study

NCT ID: NCT00686348

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2015-11-30

Brief Summary

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To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Detailed Description

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The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Conditions

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Acromegaly

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The patient must have a clinical diagnosis of acromegaly
* The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot)
* The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.

Exclusion Criteria

* Symptomatic, untreated biliary lithiasis
* Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen (formerly Tercica, Inc.)

Locations

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Ipsen

Basking Ridge, New Jersey, United States

Site Status

Countries

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United States

References

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Salvatori R, Gordon MB, Woodmansee WW, Ioachimescu AG, Carver DW, Mirakhur B, Cox D, Molitch ME. A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry. Pituitary. 2017 Dec;20(6):605-618. doi: 10.1007/s11102-017-0821-y.

Reference Type DERIVED
PMID: 28741071 (View on PubMed)

Related Links

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http://www.somatulinedepot.com/

Tercica Somatuline Depot General Information

Other Identifiers

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A-TL-52030-225 (MS319)

Identifier Type: -

Identifier Source: org_study_id

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