ConstipationPhase 2ACCESSNCT01007123

Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation

A Phase 2 study testing A3309 in people with Constipation and Chronic Constipation, run by Albireo at 44 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Constipation, Chronic Constipation
What is being tested?: A3309
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 44 sitesUnited States
Study dates: Nov 2009to Oct 2010
Phase: Phase 2
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient meets protocol specified criteria for constipation
Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Who cannot join

Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
Patient reports loose stools
Patient has IBS with pain/discomfort as predominant symptom
Patient needs medications prohibited as specified in the protocol

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Albireo Investigative Site
Albuquerque, New Mexico, 87108
Albireo Investigative Site
Anaheim, California, 92801
Albireo Investigative Site
Anderson, South Carolina, 29621
Albireo Investigative Site
Annapolis, Maryland, 21401
Albireo Investigative Site
Baltimore, Maryland, 21215
Albireo Investigative Site
Boynton Beach, Florida, 33426
Albireo Investigative Site
Chandler, Arizona, 85224
Albireo Investigative Site
Charlotte, North Carolina, 28211
Albireo Investigative Site
Chattanooga, Tennessee, 37411
Albireo Investigative Site
Chesterfield, Michigan, 48047
Albireo Investigative Site
Cincinnati, Ohio, 45224
Albireo Investigative Site
Cincinnati, Ohio, 45242
Albireo Investigative Site
Clive, Iowa, 50325
Albireo Investigative Site
Colorado Springs, Colorado, 80904
Albireo Investigative Site
Davenport, Iowa, 52807
Albireo Investigative Site
Dayton, Ohio, 45440
Albireo Investigative Site
El Paso, Texas, 79905
Albireo Investigative Site
Encinitas, California, 92024
Albireo Investigative Site
Great Neck, New York, 11021
Albireo Investigative Site
Greensboro, North Carolina, 27408
Albireo Investigative Site
Harrisburg, North Carolina, 28075
Albireo Investigative Site
Henderson, Nevada, 89104
Albireo Investigative Site
Hollywood, Maryland, 20636
Albireo Investigative Site
Huntsville, Alabama, 35801
Albireo Investigative Site
Inverness, Florida, 34452
Albireo Investigative Site
Kingsport, Tennessee, 37660
Albireo Investigative Site
La Crosse, Wisconsin, 54601
Albireo Investigative Site
Levittown, Pennsylvania, 19056
Albireo Investigative Site
Longview, Texas, 75605
Albireo Investigative Site
Lynchburg, Virginia, 24502
Albireo Investigative Site
Marlton, New Jersey, 08053
Albireo Investigative Site
Mission, Kansas, 66202
Albireo Investigative Site
Monroe, Louisiana, 71201
Albireo Investigative Site
Ogden, Utah, 84405
Albireo Investigative Site
Oklahoma City, Oklahoma, 73116
Albireo Investigative Site
Overland Park, Kansas, 66215
Albireo Investigative Site
Peoria, Illinois, 61602
Albireo Investigative Site
Phoenix, Arizona, 85020
Albireo Investigative Site
Salt Lake City, Utah, 84107
Albireo Investigative Site
San Antonio, Texas, 78229
Albireo Investigative Site
San Diego, California, 92108
Albireo Investigative Site
Shreveport, Louisiana, 71103
Albireo Investigative Site
Statesville, North Carolina, 28625
Albireo Investigative Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Conditions: Constipation, Chronic Constipation
Being tested: A3309
Keywords: Chronic idiopathic constipation, A3309
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A3309Drug
A3309 in three different dosage levels or placebo once daily for the duration of the study

Study groups in NCT01007123
Study group	Role	What they receive
A3309 low dose	Experimental	Administered once daily for the duration of the study Receives: Drug: A3309
A3309 intermediate dose	Experimental	Administered once daily for the duration of the study. Receives: Drug: A3309
A3309 high dose	Experimental	Administered once daily for the duration of the study Receives: Drug: A3309
Placebo	Placebo comparator	Administered once daily for the duration of the study Receives: Drug: A3309

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Frequency of Spontaneous Bowel Movements
Primary ep W 1
Measured: Baseline, weekly, up to 8 weeks

Secondary outcomes (5)

Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
A CSBM responder is defined as per FDA draft guidance for IBS-C:
An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Measured: Baseline, weekly and up to 8 weeks
Time to First Bowel Movement
Measured: First week
Stool Consistency Change From Baseline
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Measured: Baseline, weekly and up to 8 weeks
LDL/HDL Ratio
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Measured: Baseline and 8 weeks of treatment
Straining Change From Baseline
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Measured: Baseline and during 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Oct 2010

First posted3 Nov 2009 (estimated)
Study startNov 2009
Primary completionOct 2010
Study completionOct 2010

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 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01007123
Sponsor's protocol ID: A3309-002
Acronym: ACCESS
Status last verified: Feb 2017
First submitted: 2 Nov 2009
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chey WD, Camilleri M, Chang L, Rikner L, Graffner H. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011 Oct;106(10):1803-12. doi: 10.1038/ajg.2011.162. Epub 2011 May 24.
PubMed 21606974

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

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic 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)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation
ClinicalTrials.gov ID: NCT01007123
Acronym / sponsor ID: ACCESS / A3309-002
Conditions: Constipation, Chronic Constipation
Keywords: Chronic idiopathic constipation, A3309
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: AlbireoIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 3 Nov 2009 (estimated)
Results: Posted 22 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
A3309 low dose	Experimental	Drug: A3309Administered once daily for the duration of the study
A3309 intermediate dose	Experimental	Drug: A3309Administered once daily for the duration of the study.
A3309 high dose	Experimental	Drug: A3309Administered once daily for the duration of the study
Placebo	Placebo comparator	Drug: A3309Administered once daily for the duration of the study

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient meets protocol specified criteria for constipation
Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Key exclusion criteria (4 listed)

Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
Patient reports loose stools
Patient has IBS with pain/discomfort as predominant symptom
Patient needs medications prohibited as specified in the protocol

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
A3309A3309 in three different dosage levels or placebo once daily for the duration of the study	Drug	A3309 high dose, A3309 intermediate dose, A3309 low dose, Placebo

Primary outcome

Change From Baseline in Frequency of Spontaneous Bowel Movements
Time frame: Baseline, weekly, up to 8 weeks
Primary ep W 1

5 secondary outcomes

Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
Time frame: Baseline, weekly and up to 8 weeks
Time to First Bowel Movement
Time frame: First week
Stool Consistency Change From Baseline
Time frame: Baseline, weekly and up to 8 weeks
LDL/HDL Ratio
Time frame: Baseline and 8 weeks of treatment
Straining Change From Baseline
Time frame: Baseline and during 8 weeks of treatment

Results and safety

Results posted to the registry on 22 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elobixibat (A3309) 5 mg	48	42
Elobixibat (A3309) 10 mg	47	41
Elobixibat (A3309) 15 mg	48	37
Placebo	47	41

Primary outcome: Change From Baseline in Frequency of Spontaneous Bowel Movements

Time frame: Baseline, weekly, up to 8 weeks. Least squares mean (Standard Error). Unit: Number of SBMs

Measure	Elobixibat (A3309) 5 mg n = 46	Elobixibat (A3309) 10 mg n = 43	Elobixibat (A3309) 15 mg n = 44	Placebo n = 46
Value	2.5 (0.7)	4.0 (0.7)	5.4 (0.71)	1.7 (0.7)

Elobixibat (A3309) 5 mg vs Placebo: p <0.2, ANCOVA
Elobixibat (A3309) 10 mg vs Placebo: p = 0.002, ANCOVA
Elobixibat (A3309) 15 mg vs Placebo: p <0.001, ANCOVA

Population analysed: ITT population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization to end of follow-up 14 days after end of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elobixibat (A3309) 5 mg	1 of 48 (2.1%)	5 of 48 (10.4%)	Not reported
Elobixibat (A3309) 10 mg	1 of 47 (2.1%)	5 of 47 (10.6%)	Not reported
Elobixibat (A3309) 15 mg	0 of 48 (0%)	13 of 48 (27.1%)	Not reported
Placebo	1 of 47 (2.1%)	3 of 47 (6.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21606974Chey WD, Camilleri M, Chang L, Rikner L, Graffner H. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011 Oct;106(10):1803-12. doi: 10.1038/ajg.2011.162. Epub 2011 May 24.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic 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)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

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.

Hans Graffner, MD study chair

Albireo

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A3309 in people with Constipation and Chronic Constipation, run by Albireo at 44 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 2 inclusion and 4 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 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?

Yes. Results are posted in the registry (first posted 22 Mar 2017). 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?

Change From Baseline in Frequency of Spontaneous Bowel Movements (time frame: Baseline, weekly, up to 8 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 NCT01007123, 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 22 Mar 2017.