Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

This study is currently recruiting participants.

Verified by Indevus Pharmaceuticals, October 2008

Sponsored by:	Indevus Pharmaceuticals
Information provided by:	Indevus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00765323

Purpose

Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

Condition	Intervention	Phase
Acromegaly	Drug: Octreotide Implant Drug: Sandostatin LAR Depot	Phase III

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Octreotide Octreotide acetate Somatotropin Somatropin Somatostatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly

Further study details as provided by Indevus Pharmaceuticals:

Primary Outcome Measures:

Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 84 mg octreotide implant	Drug: Octreotide Implant 84 mg octreotide implant (6 month implant)
2: Active Comparator Injections of S-LAR	Drug: Sandostatin LAR Depot Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients with acromegaly
Confirmed diagnosis of a growth hormone-secreting tumor
Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH < 5.0 ng/mL

Exclusion Criteria:

Patients with pituitary surgery less than 3 months prior to screening
Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%
Symptomatic cholelithiasis
Received pegvisomant or a dopamine agonist within 3 months of screening, or at any time during the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765323

Contacts

Contact: Mark Roessel

781-402-3468

mroessel@indevus.com

Locations

United States, Colorado
	Recruiting
Denver, Colorado, United States
United States, Illinois
	Recruiting
Chicago, Illinois, United States
United States, Maryland
	Recruiting
Baltimore, Maryland, United States
United States, Oregon
	Recruiting
Portland, Oregon, United States
United States, Washington
	Recruiting
Seattle, Washington, United States
Czech Republic
	Recruiting
Hradec Kralove, Czech Republic
	Recruiting
Prague, Czech Republic
Germany
	Recruiting
Berlin, Germany
	Recruiting
Marburg, Germany
	Recruiting
Frankfurt, Germany
Hungary
	Recruiting
Pecs, Hungary
	Recruiting
Debrecen, Hungary
	Recruiting
Budapest, Hungary
Poland
	Recruiting
Wroclaw, Poland
	Recruiting
Szczecin, Poland
	Recruiting
Poznan, Poland
	Recruiting
Gdansk, Poland
	Recruiting
Warsaw, Poland
Russian Federation
	Recruiting
Novosibirsk, Russian Federation
	Recruiting
Moscow, Russian Federation
	Recruiting
Yaroslavl, Russian Federation
	Recruiting
Perm, Russian Federation
	Recruiting
Kemerovo, Russian Federation
	Recruiting
Barnaul, Russian Federation
	Recruiting
Samara, Russian Federation
	Recruiting
Tomsk, Russian Federation
	Recruiting
Krasnoyarsk, Russian Federation
	Recruiting
St. Petersburg, Russian Federation

Sponsors and Collaborators

Indevus Pharmaceuticals

More Information

Responsible Party:	Indevus Pharmaceuticals ( Mark Roessel )
Study ID Numbers:	IP107-001
Study First Received:	September 30, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00765323
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indevus Pharmaceuticals:

Octreotide
Sandostatin LAR
Growth hormone
IGF-1

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Musculoskeletal Diseases
Octreotide
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Somatostatin
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009