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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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.

City, postcode or hospital

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

Other trials in United States

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 groups in NCT01993875
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.

Oct 2013Jan 2014

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
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)

All Chronic Idiopathic Constipation trials

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.

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

Results posted to the registry on 13 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lubiprostone	82	75
Placebo	82	76

Primary outcome: Number of Spontaneous Bowel Movements (SBMs) Within 1 Week

Time frame: within 1 week. Mean (Standard Deviation). Unit: number of SBMs

Measure	Lubiprostone n = 82	Placebo n = 82
Value	4.6 (3.33)	4.0 (3.50)

Lubiprostone vs Placebo: p = 0.1290, ANCOVA

Population analysed: Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 Weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lubiprostone	0 of 82 (0%)	21 of 82 (25.6%)	0 of 82
Placebo	0 of 82 (0%)	15 of 82 (18.3%)	0 of 82

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 recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
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)

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?

On the ClinicalTrials.gov record for NCT01993875.

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.