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NCT00994110 · ClinicalTrials.gov registry record · Phase 3
Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
A Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
NCT00994110: Completed Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00994110 is a Phase 3 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 439 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00994110, a Phase 3 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
Study Summary
The purpose of this study is to help us learn more about how to lower the patient's risk of the most common complications after their pancreas operation. After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur. This fluid may form an "abscess" (collection of pus) or "fistula" that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries. Complications like these extend the patient's stay in the hospital after surgery. These complications may require the patient's doctor to perform additional tests or procedures to treat them. The physical and emotional burden these complications place upon patients, as well as the financial cost to the health care system, can be great. The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has been observed to reduce the rate of similar complications in other studies. The surgeon would like to compare the effects, good and/or bad, of SOM230 with "placebo" (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and abscesses.
Interventions
- OTHER placebo
- DRUG Pasireotide (SOM230)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00994110
The ClinicalTrials.gov registry entry for NCT00994110 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 439 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00994110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00994110 about?
NCT00994110 is a clinical study titled "Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess". The purpose of this study is to help us learn more about how to lower the patient's risk of the most common complications after their pancreas operation. After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur. ...
What is the current status of trial NCT00994110?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2009-10. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00994110?
The interventions under investigation include: placebo (OTHER), Pasireotide (SOM230) (DRUG).
Who is sponsoring clinical trial NCT00994110?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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