Chronic Idiopathic ConstipationPhase 2NCT02392546
Elobixibat Colonic Motor Function Study
A Phase 2 study testing elobixibat in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 1 site in United States.
Trial summary
This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- elobixibat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-65 years of age
- Body Mass Index of 18-40 kg/m2
- Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period
Who cannot join
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders.
- Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin reuptake inhibitor and newer antidepressants
- Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants
- The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
- Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. Any candidate participants with such disorder mentioned will be referred to their general physician
- The Hospital Anxiety and Depression Scale (HADS) will be used to exclude patients with significant affective disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation
This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- elobixibat, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elobixibatDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Elobixibat 10 mg | Experimental | elobixibat Receives: Drug: elobixibat |
| Elobixibat 15 mg | Experimental | elobixibat Receives: Drug: elobixibat |
| Elobixibat 20 mg | Experimental | elobixibat Receives: Drug: elobixibat |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postprandial High Amplitude Propagated Contractions (HAPCs)
Measured: At Day 7
Postprandial Colonic Tone
Measured: At Day 7
Change in postprandial tone relative to fasting
Measured: At Day 7
Secondary outcomes (5)
Fasting colonic tone
Measured: At Day 7
Colonic sensation threshold for first sensation
Measured: At Day 7
Colonic sensation threshold for gas
Measured: At Day 7
Colonic sensation threshold for pain
Measured: At Day 7
Total 48h fecal bile acid excretion
Measured: At Day 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392546
- Sponsor's protocol ID
- 000185
- Status last verified
- Jun 2015
- First submitted
- 13 Mar 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT02392546
- Acronym / sponsor ID
- 000185
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elobixibat 10 mg | Experimental | Drug: elobixibatelobixibat |
| Elobixibat 15 mg | Experimental | Drug: elobixibatelobixibat |
| Elobixibat 20 mg | Experimental | Drug: elobixibatelobixibat |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18-65 years of age
- Body Mass Index of 18-40 kg/m2
- Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period
Key exclusion criteria (6 listed)
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders.
- Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin reuptake inhibitor and newer antidepressants
- Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants
- The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
- Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. Any candidate participants with such disorder mentioned will be referred to their general physician
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 |
|---|---|---|
| elobixibat | Drug | Elobixibat 10 mg, Elobixibat 15 mg, Elobixibat 20 mg |
| placebo | Drug | Placebo |
Primary outcome
Number of postprandial High Amplitude Propagated Contractions (HAPCs)
Time frame: At Day 7
Postprandial Colonic Tone
Time frame: At Day 7
Change in postprandial tone relative to fasting
Time frame: At Day 7
5 secondary outcomes
Fasting colonic tone
Time frame: At Day 7
Colonic sensation threshold for first sensation
Time frame: At Day 7
Colonic sensation threshold for gas
Time frame: At Day 7
Colonic sensation threshold for pain
Time frame: At Day 7
Total 48h fecal bile acid excretion
Time frame: At Day 4-6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing elobixibat in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Jun 2015. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 postprandial High Amplitude Propagated Contractions (HAPCs) (time frame: At Day 7). The study lists 3 primary outcomes in all. 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 3 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.