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STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
Plain-language guide to NCT00050635: phase 4 randomized trial of Octreotide, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00050635
- Phase
- phase 4
- Status
- completed
- Start
- 2002-12
- Completion (planned or actual)
- 2003-07
- Participants
- 150
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Neoplasms; Diarrhea
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Octreotide.
Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea.
Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently.
The registry classes the interventions as drug.
Who Took Part
The registry lists 150 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: females who are pregnant or lactating,; known hypersensitivity to sandostatin, sandostatin lar ® depot or other related drug or compound,; history or presence of crohn™s disease, ulcerative colitis, sprue, or known c. difficile infection, or any other diarrheal syndrome,.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Octreotide study did not mask who received what.
It started in 2002-12 with completion listed for 2003-07.
It ran at 34 sites in United States (34).
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide in 150 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.