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Trial record 10 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes" | United States

3030-401-002 ELX BAM Study

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ClinicalTrials.gov Identifier: NCT03441581
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the possibility of a differential effect of eluxadoline on altered bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) patients with and without evidence of Bile Acid Malabsorption (BAM).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhea Drug: Eluxadoline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3030-401-002: An Open-Label Pilot Study of Eluxadoline in Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Eluxadoline

Arm Intervention/treatment
Experimental: Cohort 1
IBS-D participants with evidence of BAM treated with Eluxadoline 100 mg oral tablets twice daily (BID) with food.
Drug: Eluxadoline
Eluxadoline 100 mg oral tablets BID with food.

Experimental: Cohort 2
IBS-D participants without evidence of BAM treated with Eluxadoline 100 mg oral tablets BID with food.
Drug: Eluxadoline
Eluxadoline 100 mg oral tablets BID with food.




Primary Outcome Measures :
  1. Change from baseline in average Bristol Stool Form Scale (BSFS) score over 4 weeks of treatment period [ Time Frame: Baseline to Week 4 ]
    Change from baseline in the stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Separate hard lumps like nuts) to 7 (Watery).

  2. Percentage of Participants with Treatment Emergent Adverse Events [ Time Frame: Baseline to Week 4 ]
  3. Percentage of participants who experienced clinically significant change in Laboratory Tests [ Time Frame: Baseline to Week 4 ]
  4. Percentage of Participants who experienced clinically significant change in Vital Signs [ Time Frame: Baseline to Week 4 ]
  5. Percentage of Participants with Change from Baseline in General Physical Condition as Measured through General Physical Exam [ Time Frame: Baseline to Week 4 ]

Secondary Outcome Measures :
  1. Change from baseline in the 4-week average of daily bowel movement frequency during the treatment period [ Time Frame: Baseline to Week 4 ]
    Change from baseline in the number of bowel movements.

  2. Change from baseline in the 4-week average of daily worst abdominal pain scores during the treatment period [ Time Frame: Baseline to Week 4 ]
    Change from baseline of the average daily worst abdominal pain score.

  3. Change from baseline in the 4-week average of daily bloating scores during the treatment period [ Time Frame: Baseline to Week 4 ]
    Change from baseline of the abdominal bloating.

  4. Change from baseline in the 4-week average of urgency-free days in a week during the treatment period [ Time Frame: Baseline to Week 4 ]
    Change from baseline of the number of daily urgent bowel movements.

  5. Proportion of participants with any fecal incontinence during the treatment period [ Time Frame: Baseline to Week 4 ]
    The proportion of patients with fecal incontinence

  6. Change from baseline in IBS-QOL score at the end of the treatment period [ Time Frame: Baseline to Week 4 ]
    The IBS-QoL questionnaire will be completed by participants at the study site at Baseline prior to the administration of study drug, and Week 4.

  7. Change from baseline in serum 7αC4 levels at the end of the treatment period [ Time Frame: Baseline to Week 4 ]
    Fasting serum 7αC4 level will be measured Baseline and at Week 4 to determine whether any changes occurred following treatment.

  8. Cmax: Maximum Plasma concentration [ Time Frame: Week 2 ]
  9. Cmin: Minimum Plasma Concentration [ Time Frame: Week 2 ]
  10. AUCtau: Area under the plasma concentration-time curve during the dosing interval [ Time Frame: Week 2 ]
  11. Tmax: Time to Cmax [ Time Frame: Week 2 ]
  12. t1/2: Half-Life [ Time Frame: Week 2 ]
  13. CL: Apparent clearance for eluxadoline [ Time Frame: Week 2 ]
  14. V: Apparent volume of distribution for eluxadoline [ Time Frame: Week 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men or women aged 18 to 65 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
  • Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) > 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.
  • Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.
  • Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
  • Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
  • Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
  • Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion Criteria:

  • Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
  • Does not have a gallbladder.
  • Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
  • Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
  • Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
  • Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
  • Has Celiac disease or a positive serological test for celiac disease.
  • Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
  • Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
  • Has known allergies or hypersensitivity to opioids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441581


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Allergan
Investigators
Study Director: Anna Muslin Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03441581     History of Changes
Other Study ID Numbers: 3030-401-002
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allergan:
IBS-D
BAM

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
Eluxadoline
Gastrointestinal Agents