Constipation-Predominant Irritable Bowel SyndromePhase 3NCT00607971

Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

A Phase 3 study testing Renzapride in people with Constipation-Predominant Irritable Bowel Syndrome, run by Alizyme at 126 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C). Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Constipation-Predominant Irritable Bowel Syndrome
What is being tested?: Renzapride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 939 participants
Where: 126 sitesUnited States
Study dates: Apr 2006to Jun 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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Who cannot join

Subjects who are pregnant or breastfeeding

Trial locations and contacts

126 sites in 1 country.

City, postcode or hospital

126 sites in 1 country

United States126 sites

Research Site
Anaheim, California, 92801
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Annapolis, Maryland, 21401
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Arkansas City, Kansas, 67005
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Austin, Texas, 78745
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Bellevue, Washington, 98004
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Beverly Hills, California, 90211
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Bismarck, North Dakota, 58501
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Boston, Massachusetts, 02114
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Boston, Massachusetts, 02215
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Boynton Beach, Florida, 33426
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Bristol, Connecticut, 06010
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Burbank, California, 91505
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Burlington, North Carolina, 27215
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Carmichael, California, 95608
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Cedar Knolls, New Jersey, 07927
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Cerritos, California, 90703
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Chandler, Arizona, 85225
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Charlotte, North Carolina, 28209
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Chattanooga, Tennessee, 37403
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Chattanooga, Tennessee, 37404
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Chesapeake, Virginia, 23320
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Chesterfield, Michigan, 48047
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Chula Vista, California, 91910
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Cincinnati, Ohio, 45242
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Colorado Springs, Colorado, 80904
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Columbus, Ohio, 43215
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Coral Gables, Florida, 33134
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Corsicana, Texas, 75110
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Cypress, California, 90630
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Dallas, Texas, 75231
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Dallas, Texas, 75234
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Des Moines, Iowa, 50321
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Downington, Pennsylvania, 19335
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Elkin, North Carolina, 28621
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Fargo, North Dakota, 58104
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Fayetteville, North Carolina, 28304
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Fort Worth, Texas, 76104
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Gainesville, Florida, 32607
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Germantown, Tennessee, 38138
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Great Neck, New York, 11021
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Great Neck, New York, 11023
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Greensboro, North Carolina, 27403
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Greensboro, North Carolina, 27408
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Greer, South Carolina, 29651
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Hagerstown, Maryland, 21740
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Hialeah, Florida, 33013
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Houston, Texas, 77090
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46237
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Inverness, Florida, 34452
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32207
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Jacksonville, Florida, 32256
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Johnson City, New York, 13790
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Kalamazoo, Michigan, 49048
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Kingsport, Tennessee, 37660
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Kingston, New York, 12401
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Kissimmee, Florida, 34741
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Knoxville, Tennessee, 37909
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Laguna Hills, California, 92653
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Lakewood, Colorado, 80215
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Lancaster, Pennsylvania, 17604
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Lansing, Michigan, 48910
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Laurel, Maryland, 20707
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Little Rock, Arkansas, 72205
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Littleton, Colorado, 80120
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Los Angeles, California, 90045
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Marietta, Georgia, 30067
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Memphis, Tennessee, 38120
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Mexico, Missouri, 65265
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Miami, Florida, 33173
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Milwaukee, Wisconsin, 53215
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Mineola, New York, 11501
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Mogadore, Ohio, 44260
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Murray, Utah, 84107
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Nashville, Tennessee, 37203
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New Bern, North Carolina, 28562
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New Port Richey, Florida, 34652
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New York, New York, 10021
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Newnan, Georgia, 30263
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Norman, Oklahoma, 73069
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North Little Rock, Arkansas, 72117
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Oklahoma City, Oklahoma, 73112
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Orange, California, 92868
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Orange, California, 92869
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Overland Park, Kansas, 66251
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Palm Harbor, Florida, 34684
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Pasadena, Maryland, 21122
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Passaic, New Jersey, 07055
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Pembrook Pines, Florida, 33024
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Pensacola, Florida, 32514
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Phoenix, Arizona, 85014
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15212
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Plantation, Florida, 33324
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Port Orange, Florida, 32129
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Raleigh, North Carolina, 27612
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Richmond, Virginia, 23294
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Rockford, Illinois, 61107-5078
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San Carlos, California, 94070
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San Diego, California, 92123
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San Diego, California, 92128
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San Francisco, California, 94115
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Scottsbluff, Nebraska, 69361
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Severna Park, Maryland, 21146
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Shreveport, Louisiana, 71103
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Sicklerville, New Jersey, 08090
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Sierra Vista, Arizona, 85635
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Simpsonville, South Carolina, 29681
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Spokane, Washington, 99204
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Spokane, Washington, 99207
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Springfield, Missouri, 65807
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Suffolk, Virginia, 23434
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Sylvania, Ohio, 43560
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Topeka, Kansas, 66606
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Troy, Michigan, 48098
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Tupelo, Mississippi, 38802
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Vero Beach, Florida, 32960
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Virginia Beach, Virginia, 23454
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West Palm Beach, Florida, 33409-3509
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Wichita, Kansas, 67205
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Wichita, Kansas, 67207
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Wilmington, North Carolina, 28401
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Wilmington, North Carolina, 28412
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Winston-Salem, North Carolina, 27103
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Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Read the detailed description

Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).

Conditions: Constipation-Predominant Irritable Bowel Syndrome
Being tested: Renzapride
Keywords: Constipation predominant 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
All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Study groups in NCT00607971
Study group	Role	What they receive
1	Experimental	All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52 Receives: Drug: Renzapride

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Measured: One year

Secondary outcomes (1)

Vital signs, routine clinical laboratory data, 12-lead ECG
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jun 2008

First posted6 Feb 2008 (estimated)
Study startApr 2006
Primary completionJun 2008
Study completionJun 2008

Why it stopped: Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Constipation-Predominant 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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 939 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00607971
Sponsor's protocol ID: ATL1251/052/CL
Status last verified: Jul 2008
First submitted: 23 Jan 2008
Last updated: 8 Jul 2008
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome
Not yet recruitingPhase 4
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)

All Constipation-Predominant Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
ClinicalTrials.gov ID: NCT00607971
Acronym / sponsor ID: ATL1251/052/CL
Conditions: Constipation-Predominant Irritable Bowel Syndrome
Keywords: Constipation predominant irritable bowel syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.
Enrolment: 939 participants (actual)
Lead sponsor: AlizymeIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 6 Feb 2008 (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.

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: RenzaprideAll subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Key exclusion criteria (1 listed)

Subjects who are pregnant or breastfeeding

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 24924All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52	Drug	1

Primary outcome

Adverse events
Time frame: One year

1 secondary outcome

Vital signs, routine clinical laboratory data, 12-lead ECG
Time frame: One year

Results and safety

The study was stopped early (reason given: Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.

Related trials for Constipation-Predominant Irritable Bowel Syndrome

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome
Not yet recruitingPhase 4
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)

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, MD principal investigator

Beth Israel Deaconess Medical Center, Boston

126 sites 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 Constipation-Predominant Irritable Bowel Syndrome, run by Alizyme at 126 sites 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 1 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: stopped early, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites 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. 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 was stopped early (reason given: Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.). 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?

Adverse events (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00607971.

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 8 Jul 2008.