Irritable Bowel SyndromePhase 2NCT00441766

Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

A Phase 2 study testing AGN 203818 in people with Irritable Bowel Syndrome, run by Allergan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: AGN 203818
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Feb 2008
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Irritable Bowel Syndrome
Moderate or severe IBS pain

Who cannot join

Any other uncontrolled disease
Pregnant or nursing females

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Orange, California

Other trials in United States

About this study

Conditions: Irritable Bowel Syndrome
Being tested: AGN 203818, placebo
Medical subject headings: Irritable Bowel Syndrome

What participants receive

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

AGN 203818Drug
Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks
AGN 203818Drug
Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks
AGN 203818Drug
Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks
placeboDrug
Part A: placebo capsule every 12 hours for 4 weeks

Study groups in NCT00441766
Study group	Role	What they receive
AGN 203818 3 mg	Experimental	Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks Receives: Drug: AGN 203818
AGN 203818 20 mg	Experimental	Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks Receives: Drug: AGN 203818
AGN 203818 60 mg	Experimental	Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks Receives: Drug: AGN 203818
Placebo	Placebo comparator	Part A: Placebo capsule every 12 hours for 4 weeks Receives: Drug: placebo

What is being measured

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

Change From Baseline in Mean Highest-Average-Pain Score at Week 4
Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).
Measured: Baseline, Week 4

Secondary outcomes (3)

Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4
Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An "improved" condition was defined as a score of 1, 2, or 3.
Measured: Week 4
Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4
Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a "Yes" or "No", where "Yes" indicated adequate relief of pain and "No" indicated no relief from pain.
Measured: Week 4
Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)
Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.
Measured: Baseline, Week 4

Timeline

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

Mar 2007Feb 2008

First posted1 Mar 2007 (estimated)
Study startMar 2007
Primary completionFeb 2008
Study completionFeb 2008

Why it stopped: Study was terminated due to company decision after Part A. Part B was never conducted

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 Irritable Bowel SyndromeStudies 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, Investigator, Outcomes assessor
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441766
Sponsor's protocol ID: 203818-008
Status last verified: Dec 2011
First submitted: 27 Feb 2007
Last updated: 20 Jan 2012
Results posted: Yes, on ClinicalTrials.gov

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

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
ClinicalTrials.gov ID: NCT00441766
Acronym / sponsor ID: 203818-008
Conditions: Irritable Bowel Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to company decision after Part A. Part B was never conducted
Enrolment: 213 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 1 Mar 2007 (estimated)
Results: Posted 20 Jan 2012

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: 4

Arm	Type	Receives
AGN 203818 3 mg	Experimental	Drug: AGN 203818Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks
AGN 203818 20 mg	Experimental	Drug: AGN 203818Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
AGN 203818 60 mg	Experimental	Drug: AGN 203818Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
Placebo	Placebo comparator	Drug: placeboPart A: Placebo capsule every 12 hours for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of Irritable Bowel Syndrome
Moderate or severe IBS pain

Key exclusion criteria (2 listed)

Any other uncontrolled disease
Pregnant or nursing females

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
AGN 203818Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks	Drug	AGN 203818 3 mg
AGN 203818Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks	Drug	AGN 203818 20 mg
AGN 203818Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks	Drug	AGN 203818 60 mg
placeboPart A: placebo capsule every 12 hours for 4 weeks	Drug	Placebo

Primary outcome

Change From Baseline in Mean Highest-Average-Pain Score at Week 4
Time frame: Baseline, Week 4
Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).

3 secondary outcomes

Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4
Time frame: Week 4
Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4
Time frame: Week 4
Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGN 203818 60 mg	53	39
AGN 203818 20 mg	53	46
AGN 203818 3 mg	53	44
Placebo	54	48

Primary outcome: Change From Baseline in Mean Highest-Average-Pain Score at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	AGN 203818 60 mg n = 47	AGN 203818 20 mg n = 50	AGN 203818 3 mg n = 50	Placebo n = 50
Baseline	5.8 (1.18)	5.7 (1.09)	6.0 (1.48)	6.0 (1.15)
Change from Baseline at Week 4	-2.3 (2.07)	-1.9 (1.81)	-1.7 (1.46)	-2.2 (2.15)

Population analysed: Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN 203818 60 mg	8 of 53 (15.1%)	52 of 53 (98.1%)	Not reported
AGN 203818 20 mg	0 of 53 (0%)	48 of 53 (90.6%)	Not reported
AGN 203818 3 mg	2 of 52 (3.8%)	28 of 52 (53.8%)	Not reported
Placebo	1 of 54 (1.9%)	39 of 54 (72.2%)	Not reported

Limitations and caveats (from the sponsor): Only Part A results are presented; Due to termination of the study, Part B was never conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Irritable Bowel Syndrome

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

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.

Medical Director study director

Allergan

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 AGN 203818 in people with Irritable Bowel Syndrome, run by Allergan 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 2 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: stopped early, as of the sponsor's last update on 20 Jan 2012. 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?

Yes. Results are posted in the registry (first posted 20 Jan 2012). 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 Mean Highest-Average-Pain Score at Week 4 (time frame: Baseline, Week 4). 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 NCT00441766.

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 Jan 2012.