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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
| Sucampo AG | INDUSTRY |
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A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with IBS-M/IBS-U.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Experimental | Participants receive 8 mcg lubiprostone capsules twice daily (BID) |
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| Placebo | Placebo Comparator | Participants receive 0 mcg capsules BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | 8 mcg administered orally twice daily (BID) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified as an Overall Responder for Abdominal Pain | An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks. | within 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse. A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week. | within 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader, MD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E Squared Research, Inc. | Huntsville | Alabama | 35801 | United States | ||
| Arkansas Gastroenterology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants receive 0 mcg capsules twice daily (BID) |
| FG001 | Lubiprostone | Participants receive 8 mcg lubiprostone capsules BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Care provider and outcomes assessor were also blinded
| Placebo | Drug | Matching placebo, 0 mcg administered orally twice daily (BID) |
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| Number of Participants Classified as a Monthly Responder for Abdominal Pain | A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month. | within 3 months |
| Number of Participants Classified as a Weekly Responder for Stool Consistency | A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week. | within 12 weeks |
| Number of Participants Classified as a Monthly Responder for Stool Consistency | A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month. | within 3 months |
| Number of Participants Classified as an Overall Responder for Stool Consistency | An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks. | within 3 months |
| Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms | A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms. | within 12 weeks |
| Number of Participants Classified as a Monthly Responder for IBS Symptoms | A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms. | within 3 months |
| Number of Participants Classified as an Overall Responder for IBS Symptoms | A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms. | within 3 months |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| GW Research Inc. | Chula Vista | California | 91910 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| Prestige Clinical Research Center | Miami | Florida | 33133 | United States |
| Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida | 34684 | United States |
| Meritus Center for Clinical Research | Hagerstown | Maryland | 21742 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PMG Research of Charlotte | Charlotte | North Carolina | 28210 | United States |
| PMG Research of Charlotte | Concord | North Carolina | 28025 | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Clinical Research Solutions | Jackson | Tennessee | 38305 | United States |
| Houston Endoscopy Research Center | Houston | Texas | 77079 | United States |
| Wellness Clinical Research Associates | McKinney | Texas | 75071 | United States |
| Advanced Clinical Research Associates | Plano | Texas | 75093 | United States |
| Modified Intent to Treat (mITT) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAS), defined as all participants who take at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants receive 0 mcg capsules twice daily (BID) |
| BG001 | Lubiprostone | Participants receive 8 mcg lubiprostone capsules BID |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Abdominal Pain | Participants rate their pain on a scale from 0-10, where 0=no pain and 10=the worst pain. A higher score means the pain is worse. Baseline is defined as the weekly average during the 4-week screening period. | Mean | Standard Deviation | units on a scale |
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| 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 | Number of Participants Classified as an Overall Responder for Abdominal Pain | An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks. | modified Intent to Treat (mITT), defined as all randomized subjects who take at least one dose of study medication. | Posted | Count of Participants | Participants | within 12 weeks |
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| Secondary | Number of Participants Classified as a Weekly Responder for Abdominal Pain | Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse. A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week. | mITT | Posted | Count of Participants | Participants | within 12 weeks |
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| Secondary | Number of Participants Classified as a Monthly Responder for Abdominal Pain | A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month. | mITT | Posted | Count of Participants | Participants | within 3 months |
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| Secondary | Number of Participants Classified as a Weekly Responder for Stool Consistency | A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week. | mITT | Posted | Count of Participants | Participants | within 12 weeks |
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| Secondary | Number of Participants Classified as a Monthly Responder for Stool Consistency | A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month. | mITT | Posted | Count of Participants | Participants | within 3 months |
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| Secondary | Number of Participants Classified as an Overall Responder for Stool Consistency | An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks. | mITT | Posted | Count of Participants | Participants | within 3 months |
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| Secondary | Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms | A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms. | mITT | Posted | Count of Participants | Participants | within 12 weeks |
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| Secondary | Number of Participants Classified as a Monthly Responder for IBS Symptoms | A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms. | mITT | Posted | Count of Participants | Participants | within 3 months |
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| Secondary | Number of Participants Classified as an Overall Responder for IBS Symptoms | A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms. | mITT | Posted | Count of Participants | Participants | within 3 months |
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13 weeks
Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
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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 | Placebo | Participants receive 0 mcg capsules twice daily (BID) | 0 | 34 | 0 | 34 | 8 | 34 |
| EG001 | Lubiprostone | Participants receive 8 mcg lubiprostone capsules BID | 0 | 37 | 1 | 37 | 12 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinal oedema | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Mean cell volume increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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