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A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01494233
First Posted: December 16, 2011
Last Update Posted: March 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
  Purpose
The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).

Condition Intervention Phase
Irritable Bowel Syndrome Drug: 250 mg LX1033 tablets Drug: Placebo tablet Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in stool consistency [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Change from baseline in plasma 5-HIAA levels [ Time Frame: 4 weeks ]
  • Change from baseline in worst abdominal pain in past 24 hours [ Time Frame: 4 weeks ]

Enrollment: 373
Study Start Date: February 2012
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
500 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Experimental: Mid dose
500 mg LX1033 three times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Experimental: High dose
1000 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Placebo Comparator: Placebo
Matching placebo dosing
Drug: Placebo tablet
Matching placebo tablet administered orally

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
  • Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
  • Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
  • Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
  • Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
  • Any abnormalities or conditions deemed by the investigator as clinically significant
  Contacts and Locations
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): NCT01494233


  Show 81 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Sumen Wason, MD Lexicon Pharmaceuticals, Inc.
  More Information

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01494233     History of Changes
Other Study ID Numbers: LX1033.1-201-IBS
LX1033.201 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Submitted: December 13, 2011
First Posted: December 16, 2011
Last Update Posted: March 23, 2015
Last Verified: March 2015

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