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Type(s) of Cancer
Ovarian, Colorectal, Bladder, Uterine Cervix, Prostate
Study Phase
Phase 3
Study Completion Date
July 2013
NCT01198145Uploaded 02-09-2020
Access via NCI by Request
PDS UID - nci-data-374
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Provider Information
Provider Data DescriptionDataset NCT01198145-D2 (supplemental) is one of 2 datasets associated with PubMed ID 27354129. This dataset contains information that will allow you to reproduce supplemental table 1. All Adverse events reported were collected and graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset87
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryRATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy. PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.
ConditionsDiarrhea
Gastrointestinal Complications
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDrug: sulfasalazine
Other: placebo
Drug(s)Drug: sulfasalazine
Total Enrolled87
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I: Sulfasalazine - Experimental
Arm II: Placebo - Placebo Comparator
Secondary IDNCI-2011-02602
PubMed (PMID)27354129
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT01198145-D2
Data DictionaryNCT01198145-D2-Data-Dictionary_3.pdf
DATANCT01198145-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01198145-D1
Data DictionaryNCT01198145-D1-Data-Dictionary_2.pdf
DATANCT01198145-D1-Dataset.csv
OTHERREADME.pdf
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