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)

• ClinicalTrials.gov Identifier: NCT01076699
• Recruitment Status: Suspended
• First Posted: February 26, 2010
• Last Update Posted: July 19, 2010
• Sponsor: Revogenex, Inc.
• Information provided by: Revogenex, Inc.

Tracking Information

• First Submitted Date: December 1, 2009
• First Posted Date: February 26, 2010
• Last Update Posted Date: July 19, 2010
• Study Start Date: March 2010
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 25, 2010): Change in weekly average abdominal pain severity score from baseline. [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 25, 2010)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Official Title: 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)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Irritable Bowel Syndrome

Intervention

• Drug: 0.075 mg RVX-100
  This group is taking the lowest dose of RVX-100
• Drug: 0.125 mg RVX-100
  This group is taking an average dose of RVX-100
• Drug: 0.250 mg RVX-100
  This group is taking the highest dose of RVX-100
• Drug: placebo
  This group is taking a placebo
  Other Name: Sugar pill

Study Arms

• Active Comparator: Group taking 0.075 mg RVX-100
  This group is taking 0.075 mg RVX-100
  Intervention: Drug: 0.075 mg RVX-100
• Active Comparator: Group taking 0.125 mg RVX-100
  This group is taking 0.125 mg RVX-100
  Intervention: Drug: 0.125 mg RVX-100
• Active Comparator: 0.250 mg RVX-100
  This group is taking 0.250 mg RVX-100
  Intervention: Drug: 0.250 mg RVX-100
• Placebo Comparator: placebo
  This group is taking a placebo
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: February 25, 2010): 192
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2011
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01076699
• Other Study ID Numbers: RVG-09-005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: George Kottayil, Chief Operations Officer, Revogenex
• Study Sponsor: Revogenex, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Hardi, M.D., CPI; Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

• PRS Account: Revogenex, Inc.
• Verification Date: July 2010