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Study was terminated due to company decision after Part A. Part B was never conducted
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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. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN 203818 3 mg | Experimental | Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks |
|
| AGN 203818 20 mg | Experimental | Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks |
|
| AGN 203818 60 mg | Experimental | Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks |
|
| Placebo | Placebo Comparator | Part A: Placebo capsule every 12 hours for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN 203818 | Drug | Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN 203818 60 mg | Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks |
| FG001 | AGN 203818 20 mg | Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks |
| FG002 | AGN 203818 3 mg | Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks |
| FG003 | Placebo | Part A: Placebo capsule every 12 hours for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN 203818 60 mg | Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks |
| BG001 | AGN 203818 20 mg | Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 4 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized (started the study) AND treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN 203818 60 mg | Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
Only Part A results are presented; Due to termination of the study, Part B was never conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| AGN 203818 |
| Drug |
Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks |
|
| AGN 203818 | Drug | Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks |
|
| placebo | Drug | Part A: placebo capsule every 12 hours for 4 weeks |
|
| 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. | 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. | Baseline, Week 4 |
| BG002 | AGN 203818 3 mg | Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks |
| BG003 | Placebo | Part A: Placebo capsule every 12 hours for 4 weeks |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | AGN 203818 20 mg | Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks |
| OG002 | AGN 203818 3 mg | Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks |
| OG003 | Placebo | Part A: Placebo capsule every 12 hours for 4 weeks |
|
|
| Secondary | 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. | 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. | Posted | Number | Percentage of Patients | Week 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | Percentage of Patients | Week 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Bowel Movements (Stools) Per Day | Baseline, Week 4 |
|
|
|
| 8 |
| 53 |
| 52 |
| 53 |
| EG001 | AGN 203818 20 mg | Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks | 0 | 53 | 48 | 53 |
| EG002 | AGN 203818 3 mg | Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks | 2 | 52 | 28 | 52 |
| EG003 | Placebo | Part A: Placebo capsule every 12 hours for 4 weeks | 1 | 54 | 39 | 54 |
| Adjustment Disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Blood bilirubin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Reticulocyte count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D004066 | Digestive System Diseases |
| (IBS-C) Change from Baseline at Week 4 |
|
| (IBS-D) Baseline |
|
| (IBS-D) Change from Baseline at Week 4 |
|
| (IBS-M) Baseline |
|
| (IBS-M) Change from Baseline at Week 4 |
|