Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3002)

Study Description

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Brief Summary:

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 compared with placebo in the treatment of patients with diarrhea-predominant irritable bowel syndrome.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: JNJ-27018966; Other: Placebo Comparator	Phase 3

Detailed Description:

The study will consist of a pretreatment phase (consisting of an up to 1-week prescreening period and an up to 3-week screening period) and a 30-week blinded treatment period.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Study Start Date :	May 2012
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	February 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: JNJ-270189966 75 mg twice daily	Drug: JNJ-27018966; Oral tablets twice daily
Experimental: JNJ-27018966 100 mg twice daily	Drug: JNJ-27018966; Oral tablets twice daily
Placebo Comparator: Matching placebo twice daily	Other: Placebo Comparator; Oral tablets twice daily

Outcome Measures

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Primary Outcome Measures :

1. Composite response based on improvements from baseline in daily abdominal pain and daily stool consistency scores. [ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]

Secondary Outcome Measures :

1. Pain response based on improvement from baseline in daily abdominal pain scores. [ Time Frame: Daily pain response determined to evaluate response over 12 weeks ]
2. Stool consistency response based on improvement from baseline in daily stool consistency scores. [ Time Frame: Daily stool consistency response determined to evaluate response over 12 weeks ]
3. Abdominal bloating [ Time Frame: Daily over 12 and 26 weeks ]
4. Bowel movement frequency [ Time Frame: Daily over 12 and 26 weeks ]
5. Urgency episodes [ Time Frame: Daily over 12 and 26 weeks ]
6. Incontinence episodes [ Time Frame: Daily over 12 and 26 weeks ]
7. Irritable Bowel Syndrome global symptom severity response [ Time Frame: Daily over 12 and 26 weeks ]
8. Durability of treatment based on composite response in daily abdominal pain scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ]
9. Durability of treatment based on the composite response in daily stool consistency scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ]
10. Durability of treatment based on the composite response in Irritable Bowel Syndrome global symptom severity. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-12, Weeks 1-26 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patient is 18 to 80 years old
2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria.

2. Patient has had a colonoscopy performed:

• Within 10 years prior to Prescreening if patient is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable)

• Since the onset (if applicable) of any of the following alarm features for patients of any age

  • Patient has documented weight loss within the past 6 months
  • Patient has nocturnal symptoms
  • Patient has a familial history of first-degree relatives with colon cancer
  • Patient has blood mixed with their stool (excluding blood from hemorrhoids). 3. Female patients must be:
• Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
• Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
• Abstinent, or
• If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

1. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
2. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
3. Patient has a history of diverticulitis within 3 months prior to Prescreening.
4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

5. Patient has any of the following surgical history:

   • Cholecystectomy with any history of post cholecystectomy biliary tract pain
   • Any abdominal surgery within the 3 months prior to Prescreening
   • Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.

Contacts and Locations

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Sponsors and Collaborators

Furiex Pharmaceuticals, Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.

Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.

Responsible Party:	Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01553747 History of Changes
Other Study ID Numbers:	27018966IBS3002
First Posted:	March 14, 2012
Last Update Posted:	May 13, 2015
Last Verified:	April 2015

Keywords provided by Furiex Pharmaceuticals, Inc:

Irritable bowel syndrome with diarrhea; Irritable bowel syndrome; Diarrhea predominant irritable bowel syndrome; Colonic diseases; Colonic diseases, functional; Digestive system disease	Gastrointestinal disease; Intestinal disease; Colonic pseudo-obstruction; Diarrhea; Signs and symptoms, Digestive

Additional relevant MeSH terms:

Syndrome; Diarrhea; Irritable Bowel Syndrome; Disease; Pathologic Processes; Signs and Symptoms, Digestive	Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases