Irritable Bowel SyndromePhase 2NCT02544152
Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
A Phase 2 study testing Lubiprostone in people with Irritable Bowel Syndrome, run by Sucampo Pharma Americas, LLC at 16 sites in United States.
Trial summary
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
- Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
- Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.
Who cannot join
- Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
- Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
PMG Research of Charlotte
Charlotte, North Carolina, 28210
GW Research Inc.
Chula Vista, California, 91910
PMG Research of Charlotte
Concord, North Carolina, 28025
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Houston Endoscopy Research Center
Houston, Texas, 77079
E Squared Research, Inc.
Huntsville, Alabama, 35801
Clinical Research Solutions
Jackson, Tennessee, 38305
Wellness Clinical Research Associates
McKinney, Texas, 75071
Prestige Clinical Research Center
Miami, Florida, 33133
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684
Advanced Clinical Research Associates
Plano, Texas, 75093
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Inland Empire Liver Foundation
Rialto, California, 92377
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
Read the detailed description
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with IBS-M/IBS-U.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lubiprostone, Placebo
- 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.
LubiprostoneDrug
Also called Amitiza
8 mcg administered orally twice daily (BID)
PlaceboDrug
Also called Matching Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | Participants receive 8 mcg lubiprostone capsules twice daily (BID) Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | Participants receive 0 mcg capsules BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Classified as an Overall Responder for Abdominal Pain
An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
Measured: within 12 weeks
Secondary outcomes (8)
Number of Participants Classified as a Weekly Responder for Abdominal Pain
Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse.
A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week.
Measured: within 12 weeks
Number of Participants Classified as a Monthly Responder for Abdominal Pain
A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month.
Measured: within 3 months
Number of Participants Classified as a Weekly Responder for Stool Consistency
A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week.
Measured: within 12 weeks
Number of Participants Classified as a Monthly Responder for Stool Consistency
A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month.
Measured: within 3 months
Number of Participants Classified as an Overall Responder for Stool Consistency
An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks.
Measured: within 3 months
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.
Measured: within 12 weeks
Number of Participants Classified as a Monthly Responder for IBS Symptoms
A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms.
Measured: within 3 months
Number of Participants Classified as an Overall Responder for IBS Symptoms
A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms.
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda, Sucampo AG
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544152
- Sponsor's protocol ID
- SCMP-0211-201
- Status last verified
- Mar 2018
- First submitted
- 20 Aug 2015
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)
- ClinicalTrials.gov ID
- NCT02544152
- Acronym / sponsor ID
- SCMP-0211-201
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Takeda, Sucampo AG
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 27 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
Detailed description
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with IBS-M/IBS-U.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: LubiprostoneParticipants receive 8 mcg lubiprostone capsules twice daily (BID) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive 0 mcg capsules BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
- Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
- Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.
Key exclusion criteria (3 listed)
- Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
- Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
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 |
|---|---|---|
| LubiprostoneAlso: Amitiza8 mcg administered orally twice daily (BID) | Drug | Lubiprostone |
| PlaceboAlso: Matching PlaceboMatching placebo, 0 mcg administered orally twice daily (BID) | Drug | Placebo |
Primary outcome
Number of Participants Classified as an Overall Responder for Abdominal Pain
Time frame: within 12 weeks
An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
8 secondary outcomes
Number of Participants Classified as a Weekly Responder for Abdominal Pain
Time frame: within 12 weeks
Number of Participants Classified as a Monthly Responder for Abdominal Pain
Time frame: within 3 months
Number of Participants Classified as a Weekly Responder for Stool Consistency
Time frame: within 12 weeks
Number of Participants Classified as a Monthly Responder for Stool Consistency
Time frame: within 3 months
Number of Participants Classified as an Overall Responder for Stool Consistency
Time frame: within 3 months
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
Time frame: within 12 weeks
Number of Participants Classified as a Monthly Responder for IBS Symptoms
Time frame: within 3 months
Number of Participants Classified as an Overall Responder for IBS Symptoms
Time frame: within 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Global Clinical Leader, MD study director
Mallinckrodt
16 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 Lubiprostone in people with Irritable Bowel Syndrome, run by Sucampo Pharma Americas, LLC at 16 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 3 inclusion and 3 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Yes. Results are posted in the registry (first posted 27 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Classified as an Overall Responder for Abdominal Pain (time frame: within 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 27 Dec 2019.