Irritable Bowel Syndrome (IBS)Phase 2RESTORENCT01887002
Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention 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 4 sites in United States.
Trial summary
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to Jan 2015
- 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 Chron'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
4 sites in 1 country.
United States4 sites
Boston Clinical Site
Boston, Massachusetts, 02215
Chapel Hill Clinical Site
Chapel Hill, North Carolina, 27599
Oklahoma City Clinical Site
Oklahoma City, Oklahoma, 73160
St. Louis Clinical Site
St Louis, Missouri, 63110
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- ONO-2952, Placebo comparator
- 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 Active tablets, every day for 2 weeks
Placebo comparatorDrug
ONO-2952 Matching Placebo every day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1 | Experimental | ONO-2952 Active tablets, every day for 2 weeks Receives: Drug: ONO-2952 |
| Placebo Arm | Placebo comparator | ONO-2952 Matching Placebo every day for 2 weeks Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity rating during rectal distention by using a numeric pain rating scale
Measured: 2 weeks
Secondary outcomes (1)
Safety assessed through adverse events and clinical laboratory values
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2015
Why it stopped: The study was terminated due to slow accrual of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 39 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
- NCT01887002
- Sponsor's protocol ID
- ONO-2952POU005
- Acronym
- RESTORE
- Status last verified
- Jan 2016
- First submitted
- 24 Jun 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)
- ClinicalTrials.gov ID
- NCT01887002
- Acronym / sponsor ID
- RESTORE / ONO-2952POU005
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable Bowel Syndrome, IBS, ONO-2952
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to slow accrual of subjects.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 26 Jun 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 is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1 | Experimental | Drug: ONO-2952ONO-2952 Active tablets, every day for 2 weeks |
| Placebo Arm | Placebo comparator | Drug: Placebo comparatorONO-2952 Matching Placebo every day for 2 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 Chron'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-2952ONO-2952 Active tablets, every day for 2 weeks | Drug | Experimental Arm 1 |
| Placebo comparatorONO-2952 Matching Placebo every day for 2 weeks | Drug | Placebo Arm |
Primary outcome
Change in pain intensity rating during rectal distention by using a numeric pain rating scale
Time frame: 2 weeks
1 secondary outcome
Safety assessed through adverse events and clinical laboratory values
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to slow accrual of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
4 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 4 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: stopped early, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: The study was terminated due to slow accrual of subjects.). 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 pain intensity rating during rectal distention by using a numeric pain rating scale (time frame: 2 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 25 Feb 2016.