Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

Exclusion Criteria

• •History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
• •Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
• •Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
• •Bleeding hemorrhoids at the time of enrollment.
• •Acute diverticulitis at the time of enrollment.
• •Acute or chronic pancreatitis at the time of enrollment.
• •Unmanaged celiac disease at the time of enrollment.
• •Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
• •Taking a prohibited medication.