Chronic Idiopathic ConstipationPhase 3NCT01993875
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Mallinckrodt at 11 sites in United States.
Trial summary
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic 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
- 164 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2013to Jan 2014
- 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
- Medically-confirmed diagnosis of chronic idiopathic constipation
- Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
- Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Who cannot join
- Any gastrointestinal (GI) condition, other than constipation, 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Anaheim, California, 92801
Study site
Anniston, Alabama, 36207
Study site
DeLand, Florida, 32720
Study site
Hollywood, Florida, 33024
Study site
Marlton, New Jersey, 08053
Study site
Orlando, Florida, 32809
Study site
Overland Park, Kansas, 66212
Study site
Raleigh, North Carolina, 27612
Study site
Salt Lake City, Utah, 84106
Study site
South Miami, Florida, 33143
Study site
West Bend, Wisconsin, 53095
About this study
Official title: A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
- Conditions
- Chronic Idiopathic 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
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
PlaceboDrug
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | Not described Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Measured: within 1 week
Secondary outcomes (5)
Consistency of SBMs at Week 1
Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
Measured: at Week 1
Overall Stool Consistency at Week 1
Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
Measured: at Week 1
Mean Change From Baseline in Stool Consistency at Week 1
Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).
Measured: Baseline and Week 1
Overall Straining at Week 1
Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).
Measured: Week 1
Mean Change From Baseline in Straining at Week 1
Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
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 Chronic Idiopathic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharma Americas, LLC, Takeda, Sucampo AG
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993875
- Sponsor's protocol ID
- SCMP-0211-301
- Status last verified
- Jul 2015
- First submitted
- 19 Nov 2013
- Last updated
- 13 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 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT01993875
- Acronym / sponsor ID
- SCMP-0211-301
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharma Americas, LLC, Takeda, Sucampo AG
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: Lubiprostone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically-confirmed diagnosis of chronic idiopathic constipation
- Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
- Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Key exclusion criteria (2 listed)
- Any gastrointestinal (GI) condition, other than constipation, 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 |
|---|---|---|
| LubiprostoneLiquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID) | Drug | Lubiprostone |
| PlaceboMatching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID) | Drug | Placebo |
Primary outcome
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
Time frame: within 1 week
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
5 secondary outcomes
Consistency of SBMs at Week 1
Time frame: at Week 1
Overall Stool Consistency at Week 1
Time frame: at Week 1
Mean Change From Baseline in Stool Consistency at Week 1
Time frame: Baseline and Week 1
Overall Straining at Week 1
Time frame: Week 1
Mean Change From Baseline in Straining at Week 1
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Idiopathic Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 2/3
Maralixibat in Patients With Cystic Fibrosis and Constipation
Constipation Chronic Idiopathic, Cystic Fibrosis
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 study director
Mallinckrodt
11 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 Lubiprostone in people with Chronic Idiopathic Constipation, run by Mallinckrodt at 11 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 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 13 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 11 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 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 13 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 Spontaneous Bowel Movements (SBMs) Within 1 Week (time frame: within 1 week). 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 13 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.