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)

NCT01076699 | Suspended Phase 2

• 1 other identifier: RVG-09-005
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

abdominal pain; bloating; diarrhea; irritable bowel

Outcome Measures

Primary Outcomes (1)

• Change in weekly average abdominal pain severity score from baseline.

  4 weeks

Secondary Outcomes (10)

• 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

Study Arms (4)

Group taking 0.075 mg RVX-100

ACTIVE COMPARATOR

This group is taking 0.075 mg RVX-100

Drug: 0.075 mg RVX-100

Group taking 0.125 mg RVX-100

ACTIVE COMPARATOR

This group is taking 0.125 mg RVX-100

Drug: 0.125 mg RVX-100

0.250 mg RVX-100

ACTIVE COMPARATOR

This group is taking 0.250 mg RVX-100

Drug: 0.250 mg RVX-100

placebo

PLACEBO COMPARATOR

This group is taking a placebo

Drug: placebo

Interventions

0.075 mg RVX-100 DRUG

This group is taking the lowest dose of RVX-100

Group taking 0.075 mg RVX-100

0.125 mg RVX-100 DRUG

This group is taking an average dose of RVX-100

Group taking 0.125 mg RVX-100

0.250 mg RVX-100 DRUG

This group is taking the highest dose of RVX-100

0.250 mg RVX-100

placebo DRUG

This group is taking a placebo

Also known as: Sugar pill

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revogenex, Inc.: lead

Study Sites (1)

Metropolitan Gastroenterology Group

Chevy Chase, Maryland, 20815, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain; Diarrhea

Interventions

Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Robert Hardi, M.D., CPI

  Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: February 26, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

US (1)