LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RELIANCE)

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. Identifier: NCT01257477
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Prometheus Laboratories

Brief Summary:
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.

Condition or disease
Irritable Bowel Syndrome

Detailed Description:
This observational study will evaluate the effect of Lotronex® as used in the current clinical practice setting on symptom relief, specifically, improvement in bowel habits and IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be consented for study participation. Patients will complete study questionnaires related to bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome. Investigators will also be asked to complete questionnaires related to the patient's disease characteristics, patient progress on study medication and treatment outcome.

Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Prospective
Official Title: Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment
Study Start Date : November 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in stool consistency [ Time Frame: At Week 4 and Week 12 ]
    Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.

  2. IBS pain severity [ Time Frame: At Weeks 4 and 12 ]
    Pain intensity as measured by the 11-point numeric rating scale (NRS) will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined.

Secondary Outcome Measures :
  1. Change from baseline in quality of life scores (IBSQOL). [ Time Frame: Week 12 ]
    Change from baseline in IBSQOL scores will be calculated at Week 12.

  2. Change from baseline stool frequency. [ Time Frame: Week 4 and Week 12 ]
    Stool frequency will be measured as the mean number of times per day that stools were passed, and will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined

  3. Change from baseline in fecal urgency. [ Time Frame: Week 4 and Week 12 ]
    Proportion of days with fecal urgency will be calculated for each 4-week interval and change from baseline will be determined at 4 and 12 weeks.

  4. Change from baseline in lost productivity. [ Time Frame: 12 Weeks ]
    Lost workplace productivity and number of days IBS symptoms interfered with social/leisure and household activities will be determined at baseline and week 12. Change from baseline to week 12 will be calculated.

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:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women ≥ 18 years of age with severe diarrhea-predominant IBS, who have chronic IBS symptoms lasting 6 months or longer and who have not responded adequately to other IBS therapy will be eligible to enroll in the study.

Inclusion Criteria:

  1. Be a female between 18 and 65 years of age (inclusive) at Visit 1.
  2. Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
  3. Be diagnosed with severe, diarrhea-predominant IBS.
  4. Have experienced chronic IBS symptoms lasting 6 months or longer.
  5. Have not responded adequately to other IBS therapy.
  6. Be able to read, understand and sign the informed consent and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

  1. Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
  2. In the past 14 days, has had evidence of chronic or severe constipation, or has a history of chronic or severe constipation, or a history of sequelae from constipation.
  3. Has recurrent bowel obstruction of the small intestine or colon.
  4. Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
  5. Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
  6. Has a history of thrombophlebitis or hypercoagulable state.
  7. Has a history of atherosclerosis.
  8. Has any medical or surgical condition that in the judgment of the investigator makes the patient an inappropriate candidate for Lotronex® therapy (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition; recent or ongoing malignancy; evidence of hepatic dysfunction; or renal impairment.)
  9. Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
  10. Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
  11. Chronic (≥ 6 months) use of narcotics or opioids.
  12. The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
  13. The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
  14. Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.

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 identifier (NCT number): NCT01257477

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Sponsors and Collaborators
Prometheus Laboratories
Study Director: Emil Chuang, MD Prometheus Therapeutics and Diagnostics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prometheus Laboratories Identifier: NCT01257477     History of Changes
Other Study ID Numbers: 10LOT01
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Prometheus Laboratories:
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs