title: Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients.
abstract: BACKGROUND
  Crofelemer improves bowel function in several conditions characterized by states of prominent secretory diarrhea.
  
  
  OBJECTIVE
  This double-blind, randomized, placebo-controlled trial evaluated the effects of 3 dose levels of crofelemer in patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
  
  
  METHODS
  Male and female patients were randomly assigned to receive crofelemer 125, 250 or 500 mg or placebo twice daily for 12 weeks. The primary efficacy measure was a responder for improvement in stool consistency. In addition, abdominal pain- and discomfort-free days, pain and discomfort scores as well as other bowel function parameters (such as stool frequency and consistency, urgency, bloating) were evaluated.
  
  
  RESULTS
  Two hundred and forty-two D-IBS patients were randomized. Crofelemer did not produce significant improvement in stool consistency (primary endpoint), stool frequency, urgency or adequate relief. However, female D-IBS patients showed improvement in the proportion of pain- and discomfort-free days during treatment with 500 mg crofelemer: month 1 (crofelemer vs. placebo: 17.7 vs. 10.2%, p = 0.098); month 2 (23.5 vs. 13.3%, p = 0.076); month 3 (26.1 vs. 10.6%, p = 0.0076). No benefit was seen in male D-IBS patients. Crofelemer was well tolerated.
  
  
  CONCLUSIONS
  Crofelelmer did not produce benefit on bowel function; an increase in the number of pain- and discomfort-free days in female D-IBS patients was seen. Further studies with crofelemer are warranted to evaluate it as a potential visceral analgesic.
authors.affiliation: RTI Health Solutions, Research Triangle Park, N.C. 27709, USA. amangel@rti.org
authors.forename: Allen W
authors.initials: AW
authors.lastname: Mangel
authors.forename: Pravin
authors.initials: P
authors.lastname: Chaturvedi
mesh_terms: D000328:Adult; D029802:Croton / Q000737:chemistry*; D003967:Diarrhea / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000503:physiopathology; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D044945:Proanthocyanidins / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; D044945:Proanthocyanidins; C546704:crofelemer