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Program was terminated for business reasons
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This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.
Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide | Drug | 84 mg Octreotide Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety and tolerability of the Octreotide Implant | Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site | every 3 months for up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the long term efficacy of the Octreotide Implant | Patients will have GH and IGF-1 analyzed every 3 months | every 3 months for up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | 80220 | United States | |||
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Baltimore | Maryland | 21215 | United States |
| Cleveland | Ohio | 44195 | United States |
| Portland | Oregon | 97239 | United States |
| Seattle | Washington | 98122 | United States |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |