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| Name | Class |
|---|---|
| Sucampo Pharma Americas, LLC | INDUSTRY |
| Takeda | INDUSTRY |
| Sucampo AG | INDUSTRY |
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To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Spontaneous Bowel Movements (SBMs) Within 1 Week | SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. | within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of SBMs at Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID). |
| FG001 | Placebo | Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID) |
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| at Week 1 |
| Overall Stool Consistency at Week 1 | Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. | at Week 1 |
| Mean Change From Baseline in Stool Consistency at Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean). | Baseline and Week 1 |
| Overall Straining at Week 1 | Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). | Week 1 |
| Mean Change From Baseline in Straining at Week 1 | Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value. | Week 1 |
| Anaheim |
| California |
| 92801 |
| United States |
| DeLand | Florida | 32720 | United States |
| Hollywood | Florida | 33024 | United States |
| Orlando | Florida | 32809 | United States |
| South Miami | Florida | 33143 | United States |
| Overland Park | Kansas | 66212 | United States |
| Marlton | New Jersey | 08053 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Salt Lake City | Utah | 84106 | United States |
| West Bend | Wisconsin | 53095 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Modified intent-to-treat (mITT) Population included all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID. |
| BG001 | Placebo | Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| Previous AMITIZA use at randomization | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Spontaneous Bowel Movements (SBMs) Within 1 Week | SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. | Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | number of SBMs | within 1 week |
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| Secondary | Consistency of SBMs at Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. | mITT Population | Posted | Mean | Standard Deviation | score on a scale | at Week 1 |
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| Secondary | Overall Stool Consistency at Week 1 | Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. | mITT Population | Posted | Mean | Standard Deviation | score on a scale | at Week 1 |
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| Secondary | Mean Change From Baseline in Stool Consistency at Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean). | mITT Population | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 1 |
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| Secondary | Overall Straining at Week 1 | Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). | mITT Population | Posted | Mean | Standard Deviation | Units on a scale | Week 1 |
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| Secondary | Mean Change From Baseline in Straining at Week 1 | Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value. | mITT Population | Posted | Mean | Standard Deviation | Units on a scale | Week 1 |
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Up to 7 Weeks
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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 | Lubiprostone | Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID. | 0 | 82 | 0 | 82 | 21 | 82 |
| EG001 | Placebo | Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID. | 0 | 82 | 0 | 82 | 15 | 82 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | clinicaltrials@mnk.com |
| 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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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| Yes |
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