Irritable Bowel Syndrome With ConstipationPhase 3NCT00380250
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
A Phase 3 study testing Lubiprostone in people with Irritable Bowel Syndrome With Constipation, run by Sucampo Pharma Americas, LLC.
Trial summary
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- 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
- 590 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jul 2006
- Phase
- Phase 3
- 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
- 18 years of age and older
- Stable fiber therapy
- Normal colonoscopy/sigmoidoscopy
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Experiences abdominal discomfort/pain associated with bowel movements
- Reports decreased bowel movement frequency and/or other symptoms associated with constipation
Who cannot join
- Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
- Open gastrointestinal or abdominal surgery prior to IBS onset
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
About this study
Official title: Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
- Being tested
- Lubiprostone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | 8 mcg capsule twice daily (BID) Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | Matching placebo capsule twice daily (BID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Responder Rate
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Overall responder: responder for at least 2/3 months
Measured: 12 weeks
Secondary outcomes (28)
Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
SBMs are any bowel movement not associated with rescue medication use.
Measured: Change from baseline for month 1
Month 1 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: Change from baseline for month 1
Month 1 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 1
Month 1 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline at 28 days
Month 1 Symptom Relief
Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Measured: Change from baseline for month 1
Quality of Life Change From Baseline
Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase
Measured: Change from baseline at 12 weeks
Month 2 Responder Rate
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Measured: month 2 (28 days)
Month 3 Responder Rate
Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
- Rescue medication use does not increase during the month as compared to baseline;
- No discontinuation during the month due to lack of efficacy;AND
- No ratings during the month of Moderately worse or Significantly worse.
Measured: month 3 (28 days)
Month 1 Responder Rate
Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
- Rescue medication use does not increase during the month as compared to baseline;
- No discontinuation during the month due to lack of efficacy;AND
- No ratings during the month of Moderately worse or Significantly worse.
Measured: month 1 (28 days)
Month 2 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 2
Month 3 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 3
Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Measured: Change from baseline for month 2
Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Measured: Change from baseline for month 3
Month 2 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: Change from baseline for month 2
Month 3 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: Change from baseline for month 3
Month 2 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 2
Month 3 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 3
Month 2 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 2
Month 3 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 3
Month 2 Symptom Relief
Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Measured: Change from baseline for month 2
Month 3 Symptom Relief
Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Measured: Change from baseline for month 3
Month 1 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 1
Month 1 Bowel Movement Frequency Rates Change From Baseline
Measured: Change from baseline for month 1
Month 2 Bowel Movement Frequency Rates Change From Baseline
Measured: Change from baseline for month 2
Month 3 Bowel Movement Frequency Rates Change From Baseline
Measured: Change from baseline for month 3
Month 1 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 1
Month 2 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 2
Month 3 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: Change from baseline for month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startMay 2005
- Study completionJul 2006
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies 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
- Double blind
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sucampo Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380250
- Sponsor's protocol ID
- 0211SIB-0431
- Status last verified
- Jan 2014
- First submitted
- 21 Sep 2006
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.
PubMed 19006537
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
- ClinicalTrials.gov ID
- NCT00380250
- Acronym / sponsor ID
- 0211SIB-0431
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- May 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Posted 11 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: Lubiprostone8 mcg capsule twice daily (BID) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsule twice daily (BID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- Stable fiber therapy
- Normal colonoscopy/sigmoidoscopy
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Experiences abdominal discomfort/pain associated with bowel movements
Key exclusion criteria (5 listed)
- Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
- Open gastrointestinal or abdominal surgery prior to IBS onset
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
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 |
|---|---|---|
| Lubiprostone | Drug | Lubiprostone |
| Placebo | Drug | Placebo |
Primary outcome
Overall Responder Rate
Time frame: 12 weeks
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months
28 secondary outcomes
Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
Time frame: Change from baseline for month 1
Month 1 Stool Consistency Change From Baseline
Time frame: Change from baseline for month 1
Month 1 Bowel Straining Change From Baseline
Time frame: Change from baseline for month 1
Month 1 Constipation Severity Change From Baseline
Time frame: Change from baseline at 28 days
Month 1 Symptom Relief
Time frame: Change from baseline for month 1
Quality of Life Change From Baseline
Time frame: Change from baseline at 12 weeks
Month 2 Responder Rate
Time frame: month 2 (28 days)
Month 3 Responder Rate
Time frame: month 3 (28 days)
Month 1 Responder Rate
Time frame: month 1 (28 days)
Month 2 Abdominal Bloating Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Abdominal Bloating Change From Baseline
Time frame: Change from baseline for month 3
Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
Time frame: Change from baseline for month 3
Month 2 Stool Consistency Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Stool Consistency Change From Baseline
Time frame: Change from baseline for month 3
Month 2 Bowel Straining Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Bowel Straining Change From Baseline
Time frame: Change from baseline for month 3
Month 2 Constipation Severity Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Constipation Severity Change From Baseline
Time frame: Change from baseline for month 3
Month 2 Symptom Relief
Time frame: Change from baseline for month 2
Month 3 Symptom Relief
Time frame: Change from baseline for month 3
Month 1 Abdominal Bloating Change From Baseline
Time frame: Change from baseline for month 1
Month 1 Bowel Movement Frequency Rates Change From Baseline
Time frame: Change from baseline for month 1
Month 2 Bowel Movement Frequency Rates Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Bowel Movement Frequency Rates Change From Baseline
Time frame: Change from baseline for month 3
Month 1 Abdominal Pain Change From Baseline
Time frame: Change from baseline for month 1
Month 2 Abdominal Pain Change From Baseline
Time frame: Change from baseline for month 2
Month 3 Abdominal Pain Change From Baseline
Time frame: Change from baseline for month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19006537Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.
- 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.
Medical Director, MD study director
Sucampo Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone in people with Irritable Bowel Syndrome With Constipation, run by Sucampo Pharma Americas, LLC.
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 6 inclusion and 5 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Feb 2014). 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?
Overall Responder Rate (time frame: 12 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 NCT00380250, 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 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.