Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

NCT01327300 | Completed Phase 2 Results

• 1 other identifier: 106-2010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Irritable Bowel Syndrome Treatment; Mesalamine; Anti-inflammatory drugs; 5-ASA drugs; Apriso ™

Outcome Measures

Primary Outcomes (1)

• Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo

  Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided.

  Baseline and at 12 weeks post-intervention

Secondary Outcomes (5)

• Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.

  For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)

• Functional Bowel Disorder Severity Index (FBDSI)

  An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.

• IBS - Quality of Life (IBS-QOL)Score.

  at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)

• Hospital Anxiety and Depression Scale (HADS)

  at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)

• Intestinal Permeability Testing

  At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)

Study Arms (2)

Mesalamine

ACTIVE COMPARATOR

This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.

Drug: Mesalamine

Placebo

PLACEBO COMPARATOR

This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.

Other: Placebo

Interventions

Mesalamine DRUG

Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm.

Also known as: Apriso ™

Mesalamine

Placebo OTHER

4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged 18-65 years old
• Functional Bowel Disorder Severity Index Score above 37
• Normal complete blood count, liver function studies and renal function studies
• Serologies done to rule out Celiac Spure or patient has prior negative EGD with small bowel biopsies which have been negative
• Infectious diarrhea ruled out by stool studies
• Negative colonoscopy

You may not qualify if:

• Any history of chronic liver disease, heart disease, pulmonary or renal disease
• Abnormal EKG
• Women with positive pregnancy tests
• Patient on steroids, antacids, or warfarin or chronic pain conditions other than fibromyalgia
• Patients who drink over 2oz alcohol/day on a regular basis Any other causes for diarrhea such as IBD, microscopic colitis, celiac disease, history of abdominal obstruction, pancreatitis, ileus, or any gastrointestinal bleeding.
• Patients with active malignancy in the past five years
• Patient with any history of hypersensitivity reactions to salicylate containing medications due to cross-sensitivity with mesalamine or allergy to mesalamine medications in the past
• Any subjects with fibromyalgia will be excluded from the pain testing portion only
• History of Phenylketonuria due to the aspartame contained in Apriso

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (8)

• Drossman DA, Whitehead WE, Camilleri M. Irritable bowel syndrome: a technical review for practice guideline development. Gastroenterology. 1997 Jun;112(6):2120-37. doi: 10.1053/gast.1997.v112.agast972120. No abstract available.

  PMID: 9178709 BACKGROUND

• Sandler RS. Epidemiology of irritable bowel syndrome in the United States. Gastroenterology. 1990 Aug;99(2):409-15. doi: 10.1016/0016-5085(90)91023-y.

  PMID: 2365191 BACKGROUND

• Bjarnason I, MacPherson A, Hollander D. Intestinal permeability: an overview. Gastroenterology. 1995 May;108(5):1566-81. doi: 10.1016/0016-5085(95)90708-4.

  PMID: 7729650 BACKGROUND

• Dunlop SP, Hebden J, Campbell E, Naesdal J, Olbe L, Perkins AC, Spiller RC. Abnormal intestinal permeability in subgroups of diarrhea-predominant irritable bowel syndromes. Am J Gastroenterol. 2006 Jun;101(6):1288-94. doi: 10.1111/j.1572-0241.2006.00672.x.

  PMID: 16771951 BACKGROUND

• Corinaldesi R, Stanghellini V, Cremon C, Gargano L, Cogliandro RF, De Giorgio R, Bartesaghi G, Canovi B, Barbara G. Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study. Aliment Pharmacol Ther. 2009 Aug;30(3):245-52. doi: 10.1111/j.1365-2036.2009.04041.x. Epub 2009 May 12.

  PMID: 19438846 BACKGROUND

• Gordon S, Ameen V, Bagby B, Shahan B, Jhingran P, Carter E. Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci. 2003 Jul;48(7):1317-23. doi: 10.1023/a:1024159226274.

  PMID: 12870789 BACKGROUND

• Zhou Q, Fillingim RB, Riley JL 3rd, Malarkey WB, Verne NG. Central and peripheral hypersensitivity in the irritable bowel syndrome. Pain. 2010 Mar;148(3):454-461. doi: 10.1016/j.pain.2009.12.005. Epub 2010 Jan 13.

  PMID: 20074857 BACKGROUND

• Myers CD, Robinson ME, Riley JL 3rd, Sheffield D. Sex, gender, and blood pressure: contributions to experimental pain report. Psychosom Med. 2001 Jul-Aug;63(4):545-50. doi: 10.1097/00006842-200107000-00004.

  PMID: 11485107 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Limitations and Caveats

The recruitment for this study ended on 3/2012 when Dr. Moshiree became adjunct faculty only at the University Florida. This study was limited with over 6 months of follow-up and the need for three endoscopies.

Results Point of Contact

• Title: Dr. Baharak Moshiree
• Organization: University of Florida

bmoshiree@med.miami.edu

(352)273-8393

Study Officials

• Baharak Moshiree, MD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 1, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2014-01

Locations

US (1)