At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 87 enrolled
Drug / intervention
sulfasalazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
In Brief
A Phase 3 clinical trial evaluating sulfasalazine and placebo for Diarrhea and 2 related conditions. Completed, enrolled 87 participants across 257 sites.
Detailed Summary
RATIONALE: 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Gastrointestinal Complications, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartApr 2011
Primary CompletionJul 2013
Study CompletionJul 2017
TodayJul 2026
First PostedSep 9, 2010
Enrollment StartApr 1, 2011
Primary CompletionJul 22, 2013
Study CompletionJul 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago
Interventions
sulfasalazinedrug
Given orally
placeboother
Given orally