ConstipationPhase 4NCT01096290
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
A Phase 4 study testing lubiprostone in people with Constipation, run by University of South Alabama at 1 site in United States.
Trial summary
Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2012
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female outpatient age 19 or older.
- Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
- Must include two or more of the following:
- Straining in > 1/4 defecations;
- Lumpy or hard stools > 1/4 defecations;
- Sensation of incomplete evacuation in 1/4 defecations;
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- Sensation of anorectal obstruction/blockage in > 1/4 defecations;
- <3 defecations/week.
- Loose stools are rarely present without the use of laxatives.
- There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Use of one or more of listed medications known to cause constipation.
- If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.
- Study subjects must not have received lubiprostone for more than 72 hours.
- Written informed consent.
Who cannot join
- Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- Severe diarrhea.
- Prior small bowel or colonic resection or colostomy.
- Weight < 80 lbs.
- If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.
- Positive stool hemoccult (Can be included if colonoscopic evaluation is subsequently negative).
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- Significant cardiac, renal or hepatic insufficiency.
- Pregnant or expecting to become pregnant within 120 days of study enrollment.
- Lactating or breast feeding.
- Subjects using opioid medications.
- Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
- Use of investigational drugs in the last 30 days.
- Patients with known allergy to lubiprostone.
Trial locations and contacts
1 site in 1 country.
United States1 site
USA Pavilion at Infirmary West
Mobile, Alabama, 36693
About this study
Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.
Read the detailed description
Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation and recently, constipation-predominant irritable bowel syndrome.
The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids.
In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.
- Conditions
- Constipation
- Being tested
- lubiprostone, Matched placebo
- Keywords
- constipation, lubiprostone, healthy volunteers
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostoneDrug
Also called Amitiza
24mcg BID, capsule, oral 30days
Matched placeboDrug
Also called Placebo, sugar pill
Twice daily for 30days, oral
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone 24mcg BID for 30 days | Experimental | Active medication Receives: Drug: lubiprostone |
| Placebo | Placebo comparator | Placebo, matched, blinded Receives: Drug: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of Constipation Defined by Modified ROME Criteria
Subjects will report symptoms by questionnaire
Measured: 30 days
Secondary outcomes (1)
Frequency
Subjects will report stool frequency by questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Number of needed participants could not be obtained
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Sucampo Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Jack A DiPalma, M.D., Principal investigator, University of South Alabama College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096290
- Sponsor's protocol ID
- 09-250
- Status last verified
- Nov 2020
- First submitted
- 22 Mar 2010
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
- ClinicalTrials.gov ID
- NCT01096290
- Acronym / sponsor ID
- 09-250
- Conditions
- Constipation
- Keywords
- constipation, lubiprostone, healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of needed participants could not be obtained
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Collaborators
- Takeda, Sucampo Pharmaceuticals, Inc.
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.
Detailed description
Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation and recently, constipation-predominant irritable bowel syndrome.
The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids.
In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone 24mcg BID for 30 days | Experimental | Drug: lubiprostoneActive medication |
| Placebo | Placebo comparator | Drug: Matched placeboPlacebo, matched, blinded |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult male or female outpatient age 19 or older.
- Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
- Use of one or more of listed medications known to cause constipation.
- If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.
- Study subjects must not have received lubiprostone for more than 72 hours.
Key exclusion criteria (13 listed)
- Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- Severe diarrhea.
- Prior small bowel or colonic resection or colostomy.
- Weight < 80 lbs.
- If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.
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: Amitiza24mcg BID, capsule, oral 30days | Drug | Lubiprostone 24mcg BID for 30 days |
| Matched placeboAlso: Placebo, sugar pillTwice daily for 30days, oral | Drug | Placebo |
Primary outcome
Relief of Constipation Defined by Modified ROME Criteria
Time frame: 30 days
Subjects will report symptoms by questionnaire
1 secondary outcome
Frequency
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Jack A DiPalma, M.D. principal investigator
University of South Alabama College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lubiprostone in people with Constipation, run by University of South Alabama at 1 site 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 14 inclusion and 13 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Sep 2020). 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?
Relief of Constipation Defined by Modified ROME Criteria (time frame: 30 days). 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 20 Nov 2020.