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)

Phase 2

Suspended

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: 0.075 mg RVX-100; Drug: 0.125 mg RVX-100; Drug: 0.250 mg RVX-100; Drug: placebo

• Registration Number: NCT01076699
• Lead Sponsor: Revogenex, Inc.

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 available

Study Timeline

• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-16
• Last Update Posted: 2010-07-19
• Primary Completion: 2010-12
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group taking 0.075 mg RVX-100	0.075 mg RVX-100	This group is taking 0.075 mg RVX-100
Group taking 0.125 mg RVX-100	0.125 mg RVX-100	This group is taking 0.125 mg RVX-100
0.250 mg RVX-100	0.250 mg RVX-100	This group is taking 0.250 mg RVX-100
placebo	placebo	This group is taking a placebo

Primary Outcome Measures

Name	Time	Method
Change in weekly average abdominal pain severity score from baseline.	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Metropolitan Gastroenterology Group; 🇺🇸 Chevy Chase, Maryland, United States