Irritable Bowel Syndrome With DiarrheaPhase 3ARDIS-1NCT00552565
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 3 study testing Rezular 15mg and Rezular in people with Irritable Bowel Syndrome With Diarrhea, run by AGI Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Rezular 15mg and Rezular
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfilling Rome III criteria for IBS-D
Who cannot join
- major cardiovascular disease
- psychiatric illness except mild or moderate depression
- pregnancy
- presence of other GI disease that could explain IBS-like symptoms
- history of major gastric, hepatic, pancreatic or intestinal surgery or perforation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
Read the detailed description
We have fulfilled our enrollment requirements for this study.
This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.
Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Rezular 15mg, Placebo, Rezular
- Keywords
- IBS, IBS-D, R-verapamil, Arverpamil, Rezular
- Medical subject headings
- Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezular 15mgDrug
Oral Tablets
PlaceboDrug
placebo
RezularDrug
Rezular 37.5mg 3xday up to 12 weeks
RezularDrug
Rezular 75mg 3xday up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: Rezular 15mg |
| Rezular 37.5mg | Experimental | Not described Receives: Drug: Rezular |
| Rezular - 75mg | Experimental | Not described Receives: Drug: Rezular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Relief
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 posted2 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGI Therapeutics, Inc.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552565
- Sponsor's protocol ID
- ARDIS-1
- Acronym
- ARDIS-1
- Status last verified
- Jun 2009
- First submitted
- 31 Oct 2007
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
- ClinicalTrials.gov ID
- NCT00552565
- Acronym / sponsor ID
- ARDIS-1 / ARDIS-1
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- IBS, IBS-D, R-verapamil, Arverpamil, Rezular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- AGI Therapeutics, Inc.University, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Nov 2007 (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 the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
Detailed description
We have fulfilled our enrollment requirements for this study.
This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.
Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).
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 |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: Rezular 15mg |
| Rezular 37.5mg | Experimental | Drug: Rezular |
| Rezular - 75mg | Experimental | Drug: Rezular |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fulfilling Rome III criteria for IBS-D
Key exclusion criteria (5 listed)
- major cardiovascular disease
- psychiatric illness except mild or moderate depression
- pregnancy
- presence of other GI disease that could explain IBS-like symptoms
- history of major gastric, hepatic, pancreatic or intestinal surgery or perforation
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 |
|---|---|---|
| Rezular 15mgOral Tablets | Drug | 2 |
| Placeboplacebo | Drug | 1 |
| RezularRezular 37.5mg 3xday up to 12 weeks | Drug | Rezular 37.5mg |
| RezularRezular 75mg 3xday up to 12 weeks | Drug | Rezular - 75mg |
Primary outcome
Adequate Relief
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rezular 15mg and Rezular in people with Irritable Bowel Syndrome With Diarrhea, run by AGI Therapeutics, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequate Relief (time frame: 8 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 11 Jun 2009.