Irritable Bowel SyndromePhase 2NCT01076699
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 study testing 0.075 mg RVX-100, 0.125 mg RVX-100 and 0.250 mg RVX-100 in people with Irritable Bowel Syndrome, run by Revogenex, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- 0.075 mg RVX-100, 0.125 mg RVX-100 and 0.250 mg RVX-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
About this study
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)
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
- Being tested
- 0.075 mg RVX-100, 0.125 mg RVX-100, 0.250 mg RVX-100, placebo
- Keywords
- abdominal pain, bloating, diarrhea, irritable bowel
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.075 mg RVX-100Drug
This group is taking the lowest dose of RVX-100
0.125 mg RVX-100Drug
This group is taking an average dose of RVX-100
0.250 mg RVX-100Drug
This group is taking the highest dose of RVX-100
placeboDrug
Also called Sugar pill
This group is taking a placebo
| Study group | Role | What they receive |
|---|---|---|
| Group taking 0.075 mg RVX-100 | Active comparator | This group is taking 0.075 mg RVX-100 Receives: Drug: 0.075 mg RVX-100 |
| Group taking 0.125 mg RVX-100 | Active comparator | This group is taking 0.125 mg RVX-100 Receives: Drug: 0.125 mg RVX-100 |
| 0.250 mg RVX-100 | Active comparator | This group is taking 0.250 mg RVX-100 Receives: Drug: 0.250 mg RVX-100 |
| placebo | Placebo comparator | This group is taking a placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly average abdominal pain severity score from baseline.
Measured: 4 weeks
Secondary outcomes (10)
Change in weekly average Abdominal Pain Severity score from baseline to week 8
Measured: 8 weeks
Time to response, based on abdominal pain severity scores.
Measured: 8 weeks
Proportion of subjects in each treatment arm who are weekly responders.
Measured: 8 weeks
Proportion of subjects in each treatment arm who are end-of-treatment responders
Measured: 8 weeks
Number of pain-free days per week, based on responses to the Abdominal Pain Severity scale
Measured: 8 weeks
Bowel urgency
Measured: 8 weeks
Stool consistency
Measured: 8 weeks
Stool frequency
Measured: 8 weeks
Fecal incontinence
Measured: 8 weeks
Bloating
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: recruiting/enrolling participants has halted prematurely but potentially will resume Oct
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revogenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Hardi, M.D., CPI, Principal investigator, Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076699
- Sponsor's protocol ID
- RVG-09-005
- Status last verified
- Jul 2010
- First submitted
- 1 Dec 2009
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01076699
- Acronym / sponsor ID
- RVG-09-005
- Conditions
- Irritable Bowel Syndrome
- Keywords
- abdominal pain, bloating, diarrhea, irritable bowel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: recruiting/enrolling participants has halted prematurely but potentially will resume Oct
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Revogenex, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group taking 0.075 mg RVX-100 | Active comparator | Drug: 0.075 mg RVX-100This group is taking 0.075 mg RVX-100 |
| Group taking 0.125 mg RVX-100 | Active comparator | Drug: 0.125 mg RVX-100This group is taking 0.125 mg RVX-100 |
| 0.250 mg RVX-100 | Active comparator | Drug: 0.250 mg RVX-100This group is taking 0.250 mg RVX-100 |
| placebo | Placebo comparator | Drug: placeboThis group is taking a placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.075 mg RVX-100This group is taking the lowest dose of RVX-100 | Drug | Group taking 0.075 mg RVX-100 |
| 0.125 mg RVX-100This group is taking an average dose of RVX-100 | Drug | Group taking 0.125 mg RVX-100 |
| 0.250 mg RVX-100This group is taking the highest dose of RVX-100 | Drug | 0.250 mg RVX-100 |
| placeboAlso: Sugar pillThis group is taking a placebo | Drug | placebo |
Primary outcome
Change in weekly average abdominal pain severity score from baseline.
Time frame: 4 weeks
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hardi, M.D., CPI principal investigator
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.075 mg RVX-100, 0.125 mg RVX-100 and 0.250 mg RVX-100 in people with Irritable Bowel Syndrome, run by Revogenex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly average abdominal pain severity score from baseline. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2010.