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)

This study has suspended participant recruitment.
(recruiting/enrolling participants has halted prematurely but potentially will resume Oct)
Sponsor:
Information provided by:
Revogenex, Inc.
ClinicalTrials.gov Identifier:
NCT01076699
First received: December 1, 2009
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: 0.075 mg RVX-100
Drug: 0.125 mg RVX-100
Drug: 0.250 mg RVX-100
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Revogenex, Inc.:

Primary Outcome Measures:
  • Change in weekly average abdominal pain severity score from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in weekly average Abdominal Pain Severity score from baseline to week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time to response, based on abdominal pain severity scores. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in each treatment arm who are weekly responders. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in each treatment arm who are end-of-treatment responders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Number of pain-free days per week, based on responses to the Abdominal Pain Severity scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Bowel urgency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Stool frequency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Fecal incontinence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Bloating [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076699

Locations
United States, Maryland
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States, 20815
Sponsors and Collaborators
Revogenex, Inc.
Investigators
Principal Investigator: Robert Hardi, M.D., CPI Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
  More Information

No publications provided

Responsible Party: George Kottayil, Chief Operations Officer, Revogenex
ClinicalTrials.gov Identifier: NCT01076699     History of Changes
Other Study ID Numbers: RVG-09-005
Study First Received: December 1, 2009
Last Updated: July 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Revogenex, Inc.:
abdominal pain
bloating
diarrhea
irritable bowel

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014