A Four Arm Study to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo in Subjects With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D)

A Phase 2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Four-Arm Trial to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo for the Treatment of Abdominal Pain in Patients With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D)

The purpose of this study is to determine if RVX-100 is safe and effective in treating acute abdominal pain in patients with irritable bowel syndrome accompanied by diarrhea.

Study Overview

• Status: Suspended
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: 0.075 mg RVX-100; Drug: 0.125 mg RVX-100; Drug: 0.250 mg RVX-100; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Adult male or female, aged ≥18 and ≤75 years old.
• Subject/ legal representative is able to understand and sign informed consent form.
• Have abdominal pain severity defined as weekly average of "worst abdominal pain in past 24 hours" score of ≥ 3.0 on a 0 to 10 point scale during the second week of the Baseline phase.
• Have IBS-D according to Rome III criteria and ≥25% of stools on the BSS inclusion criteria rated as 6 or 7 during the Baseline phase.
• Not pregnant, lactating, or breastfeeding.
• If a female of childbearing potential, the subject must agree to remain abstinent or practice two medically acceptable forms of contraception during the screening, baseline, treatment, and withdrawal periods. Acceptable forms of contraception include oral contraception, intrauterine devices, implantable devices, and barrier methods. If a barrier method is chosen, a double barrier is required.
• Discontinue all medications used to treat IBS symptoms (prescription and non-prescription) and prescription analgesics at least two (2) weeks prior to the start of the baseline period until after the final study visit. (Final study visit occurs two (2) weeks after the last dose of study medication.) Acetaminophen may be used as a rescue medication as long as it is carefully documented on the Case Report Form (CRF). Fiber supplements are permitted if they are taken at the same frequency and amount throughout the study and were taken during the four (4) weeks prior to the Baseline phase. This must be documented in the source document file and the CRF.
• Willing and able to comply with all study-related procedures, including not incorporating significant changes in diet.

Exclusion Criteria:

• Positive for fecal ova and parasites (O&P) or Clostridium difficile (ELISA) or other bacterial pathogens (standard stool culture) during the Screening phase.
• Taking medication for the treatment of IBS during the baseline phase (other than acetaminophen).

• Taking any treatment for IBS including any of the following classes of medications within 2 weeks prior to baseline visit (Visit 2), or at any point during the study:

  • Antispasmodic or anticholinergic agents
  • Combination products including atropine, hyoscyamine, phenobarbital, and/or scopolamine
  • Antidepressants (such as monoamine oxidase inhibitors [MAOI], selective serotonin reuptake inhibitors [SSRIs], and tricyclic antidepressants), to include, but not limited to the following:
  • Combination products including pheniramine, phenyltoloxamine, or pyrilamine
  • Laxatives
  • Opioids/narcotic analgesics
  • Phenothiazines antipsychotics and anti-emetics
• History of anticholinergic psychosis (psychosis associated with exposure to anticholinergic medications).
• Laboratory values greater than three times the upper limit of normal (ULN) alanine transaminase (ALT/SGPT) or aspartate transaminase (AST/SGOT).
• Laboratory values greater than two times the ULN for total bilirubin (TBil), creatinine (sCr) or blood urea nitrogen (BUN).
• Active infection with hepatitis (A, B, or C) or positive confirmatory test for HIV1, or HIV2 (results of the HIV testing will be kept strictly confidential. Subject may wish to undergo HIV testing as per the guidelines for HIV testing requirements in India pursuant to NACO).
• History of allergic reaction to l-hyoscyamine or atropine, or any component in the formulation of the study drugs.
• Evidence of disease (based on medical history) that could adversely affect the subject's safety during participation in this study or interfere with the interpretation of study results, including but not limited to: glaucoma; pyloric stenosis; clinically significant benign prostatic hypertrophy; clinically significant heart or lung or disease; active peptic ulcer; celiac disease; digestive tract obstruction or paralysis; myasthenia gravis; inflammatory bowel disease; poorly controlled hypertension; hyperthyroidism; decreased hepatic or renal function; urinary retention, or lactose intolerance.
• Use of any investigational drug within 30 days prior to the Baseline Visit (Visit 2), or anytime during study.
• History of non-compliance with treatment or clinical visit attendance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group taking 0.075 mg RVX-100; This group is taking 0.075 mg RVX-100	Drug: 0.075 mg RVX-100; This group is taking the lowest dose of RVX-100
Active Comparator: Group taking 0.125 mg RVX-100; This group is taking 0.125 mg RVX-100	Drug: 0.125 mg RVX-100; This group is taking an average dose of RVX-100
Active Comparator: 0.250 mg RVX-100; This group is taking 0.250 mg RVX-100	Drug: 0.250 mg RVX-100; This group is taking the highest dose of RVX-100
Placebo Comparator: placebo; This group is taking a placebo	Drug: placebo; This group is taking a placebo; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weekly average abdominal pain severity score from baseline.	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in weekly average Abdominal Pain Severity score from baseline to week 8	8 weeks
Time to response, based on abdominal pain severity scores.	8 weeks
Proportion of subjects in each treatment arm who are weekly responders.	8 weeks
Proportion of subjects in each treatment arm who are end-of-treatment responders	8 weeks
Number of pain-free days per week, based on responses to the Abdominal Pain Severity scale	8 weeks
Bowel urgency	8 weeks
Stool consistency	8 weeks
Stool frequency	8 weeks
Fecal incontinence	8 weeks
Bloating	8 weeks

Collaborators and Investigators

• Sponsor: Revogenex, Inc.
• Investigators: Principal Investigator: Robert Hardi, M.D., CPI, Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): July 19, 2010
• Last Update Submitted That Met QC Criteria: July 16, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: diarrhea; bloating; abdominal pain; irritable bowel
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: RVG-09-005