Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Tracking Information
Start Date ICMJE | September 2008 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 1, 2008) | 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 ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00765323 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly |
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Official Title ICMJE | 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 |
Brief Summary | Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment |
Condition ICMJE | Acromegaly |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 140 | ||||
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Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Czech Republic, Germany, Hungary, Poland, Russian Federation, Serbia, Slovakia, Spain |
Administrative Information
NCT ID ICMJE | NCT00765323 |
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Responsible Party | Senior Director Clinical R&D, Endo Pharmaceuticals Solutions Inc |
Study ID Numbers ICMJE | IP107-001 |
Study Sponsor ICMJE | Endo Pharmaceuticals Solutions Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Endo Pharmaceuticals Solutions Inc. |
Source: http://clinicaltrials.gov/