Irritable Bowel Syndrome (IBS)Phase 2RESTORENCT01844180
A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study testing ONO-2952 in people with Irritable Bowel Syndrome (IBS), run by Ono Pharma USA Inc at 48 sites in United States.
Trial summary
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- ONO-2952
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 48 sitesUnited States
- Study dates
- Apr 2013to Jul 2014
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18-65 years of age (inclusive)
- Diagnosed with IBS based on the following criteria (Rome III criteria):
- Symptom onset at least 6 months prior to diagnosis, and
- Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
- Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
- Improvement with defecation
Show all 9Show fewer
- Onset associated with a change in frequency of stool/defecation
- Onset associated with a change in form (appearance) of stool
- Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Who cannot join
- Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
- History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Akron Clinical Site
Akron, Ohio, 44311
Albuquerque Clinical Site
Albuquerque, New Mexico, 87102
Anniston Clinical Site
Anniston, Alabama, 36207
Billings Clinical Site
Billings, Montana, 59102
Boynton Beach Clinical Site
Boynton Beach, Florida, 33426
Carlsbad Clinical Site
Carlsbad, California, 92008
Cary Clinical Site
Cary, North Carolina, 27518
Chattanooga Clinical Site
Chattanooga, Tennessee, 37421
Chesterfield Clincial Site
Chesterfield, Michigan, 48047
Clearwater Clinical Site
Clearwater, Florida, 33756
Columbus Clinical Site
Columbus, Ohio, 43212
Dayton Clinical Site
Dayton, Ohio, 45432
Deland Clinical Site
DeLand, Florida, 32720
Germantown Clinical Site
Germantown, Tennessee, 38138
Goodyear Clinical Site
Goodyear, Arizona, 85351
Great Neck Clinical Site
Great Neck, New York, 11023
Greer Clinical Site
Greer, South Carolina, 29650
Groveport Clinical Site
Groveport, Ohio, 43125
Hialeah Clinical Site
Hialeah, Florida, 33012
Highpoint Clinical Site
Highpoint, North Carolina, 27262
Lansdale Clinical Site
Landsdale, Pennsylvania, 19446
Lauderdale Lakes Clinical Site
Lauderdale Lakes, Florida, 33319
Lebanon Clinical Site
Lebanon, New Hampshire, 03756
Logan Clinical Site
Logan, Utah, 84341
Mentor Clinical Site
Mentor, Ohio, 44060
Mt. Pleasant Clinical Site
Mt. Pleasant, South Carolina, 29464
New Orleans Clinical Site
New Orleans, Louisiana, 70115
Norman Clinical Site
Norman, Oklahoma, 73069
North Little Rock Clinical Site
North Little Rock, Arkansas, 72120
Oak Lawn Clinical Site
Oak Lawn, Illinois, 60453
Ogden Clinical Site
Ogden, Utah, 84405
Orlando Clinical Site
Orlando, Florida, 32806
Pasadena Clinical Site
Pasadena, Texas, 77505
Plano Clinial Site
Plano, Texas, 75075
Port Orange Clinical Site
Port Orange, Florida, 32129
Raleigh Clinical Site
Raleigh, North Carolina, 27612
Reno Clinical Site
Reno, Nevada, 89511
Salt Lake City Clinical Site
Salt Lake City, Utah, 84107
San Antonio Clinical Site
San Antonio, Texas, 78229
San Diego Clinical Site
San Diego, California, 92114
Sandy Clinical Site
Sandy City, Utah, 84094
South Miami Clinical Site
South Miami, Florida, 33143
St. Petersburg Clinical Site
St. Petersburg, Florida, 33709
Tampa Clinical Site
Tampa, Florida, 33606
Tucson Clinical Site
Tucson, Arizona, 85712
West Palm Clinical Site
West Palm, Florida, 33409
Wichita Clinical Site
Wichita, Kansas, 67203
Winston-Salem Clinical Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- ONO-2952, ONO-2952 Matching Placebo
- Keywords
- Irritable Bowel Syndrome, IBS, ONO-2952
- 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.
ONO-2952Drug
ONO-2952 Matching PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1 | Experimental | ONO-2952 low dose every day for 4 weeks Receives: Drug: ONO-2952 |
| Experimental Arm 2 | Experimental | ONO-2952 high dose every day for 4 weeks Receives: Drug: ONO-2952 |
| Placebo Arm | Placebo comparator | ONO-2952 Matching Placebo every day for 4 weeks Receives: Drug: ONO-2952 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
Measured: 4 weeks
Secondary outcomes (2)
Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
Measured: 4 weeks
Safety assessed through adverse events and clinical laboratory values
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844180
- Sponsor's protocol ID
- ONO-2952POU004
- Acronym
- RESTORE
- Status last verified
- Mar 2016
- First submitted
- 24 Apr 2013
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7.
PubMed 27910150
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT01844180
- Acronym / sponsor ID
- RESTORE / ONO-2952POU004
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable Bowel Syndrome, IBS, ONO-2952
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 1 May 2013 (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 objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1 | Experimental | Drug: ONO-2952ONO-2952 low dose every day for 4 weeks |
| Experimental Arm 2 | Experimental | Drug: ONO-2952ONO-2952 high dose every day for 4 weeks |
| Placebo Arm | Placebo comparator | Drug: ONO-2952 Matching PlaceboONO-2952 Matching Placebo every day for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female 18-65 years of age (inclusive)
- Diagnosed with IBS based on the following criteria (Rome III criteria):
- Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Key exclusion criteria (2 listed)
- Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
- History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
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 |
|---|---|---|
| ONO-2952 | Drug | Experimental Arm 1, Experimental Arm 2 |
| ONO-2952 Matching Placebo | Drug | Placebo Arm |
Primary outcome
Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
Time frame: 4 weeks
2 secondary outcomes
Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
Time frame: 4 weeks
Safety assessed through adverse events and clinical laboratory values
Time frame: 4 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 Apr 2016.
- Derived from this study: PubMed 27910150Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7.
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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.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2952 in people with Irritable Bowel Syndrome (IBS), run by Ono Pharma USA Inc at 48 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 9 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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. 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?
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?
Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS) (time frame: 4 weeks). 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 NCT01844180, which also lists 1 linked publication.
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 Apr 2016.