Irritable Bowel SyndromePhase 3NCT00268879
Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)
A Phase 3 study testing Renzapride in people with Irritable Bowel Syndrome, run by Alizyme at 1 site in United Kingdom.
Trial summary
The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Renzapride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,821 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to Jan 2008
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with constipation predominant IBS as defined by the Rome II criteria
- Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease
Who cannot join
- Patients who have diarrhoea predominant or alternating symptom IBS
- Other gastrointestinal diseases that affect bowel transit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)
The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.
In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Renzapride
- Keywords
- Irritable bowel syndrome, Constipation-predominant irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenzaprideDrug
Also called ATL-1251, BRL-24924
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. Receives: Drug: Renzapride |
| 2 | Experimental | Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. Receives: Drug: Renzapride |
| 3 | Experimental | Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. Receives: Drug: Renzapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of months a patient is a Responder for overall relief of IBS symptoms
Measured: 12 weeks
Secondary outcomes (1)
Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alizyme
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony Lembo, Principal investigator, Beth Israel Deaconess Medical Centre, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268879
- Sponsor's protocol ID
- ATL1251/038/CL
- Status last verified
- Feb 2008
- First submitted
- 22 Dec 2005
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)
- ClinicalTrials.gov ID
- NCT00268879
- Acronym / sponsor ID
- ATL1251/038/CL
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Constipation-predominant irritable bowel syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,821 participants (actual)
- Lead sponsor
- AlizymeIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Dec 2005 (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 investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.
Detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.
In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: RenzaprideTwo capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. |
| 2 | Experimental | Drug: RenzaprideRenzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. |
| 3 | Experimental | Drug: RenzaprideRenzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females with constipation predominant IBS as defined by the Rome II criteria
- Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease
Key exclusion criteria (2 listed)
- Patients who have diarrhoea predominant or alternating symptom IBS
- Other gastrointestinal diseases that affect bowel transit
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 |
|---|---|---|
| RenzaprideAlso: ATL-1251, BRL-24924Placebo Renzapride 4 mg QD Renzapride 2 mg BID | Drug | 1, 2, 3 |
Primary outcome
Number of months a patient is a Responder for overall relief of IBS symptoms
Time frame: 12 weeks
1 secondary outcome
Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention
Time frame: 12 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 15 Feb 2008.
Related trials for 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.
Anthony Lembo principal investigator
Beth Israel Deaconess Medical Centre, Boston
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 Renzapride in people with Irritable Bowel Syndrome, run by Alizyme at 1 site in United Kingdom.
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 2 inclusion and 2 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 15 Feb 2008. 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 Kingdom. 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?
Number of months a patient is a Responder for overall relief of IBS symptoms (time frame: 12 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 15 Feb 2008.