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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Experimental | 8 mcg capsule twice daily (BID) |
|
| Placebo | Placebo Comparator | Matching placebo capsule twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | SBMs are any bowel movement not associated with rescue medication use. | Change from baseline for month 1 |
| Month 1 Stool Consistency Change From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sucampo Pharmaceuticals, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19006537 | Result | Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4. |
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Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0
First subject entered 5/12/05; Last subject observation 7/18/08; Multicenter study performed at 65 study sites/centers across the US
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone Study Period I | Subjects who received active drug |
| FG001 | Placebo Study Period I | Subjects who received placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Baseline participants data is taken from the intent to treat(ITT) population Whereas the Participant flow data is for all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone Study Period I | Subjects who received active drug |
| BG001 | Placebo Study Period I | Subjects who received placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | SBMs are any bowel movement not associated with rescue medication use. | ITT with LOCF | Posted | Mean | Standard Deviation | SBM/week | Change from baseline for month 1 |
|
Up to 12 weeks
Any subject who took at least 1 dose of study medication made up the safety population. The N of this population is different from both the total subjects randomized and the ITT population
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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 Study Period I | 8 mcg capsules twice daily (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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|
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
| Change from baseline for month 1 |
| Month 1 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 1 |
| Month 1 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline at 28 days |
| Month 1 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | Change from baseline for month 1 |
| Quality of Life Change From Baseline | Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase | Change from baseline at 12 weeks |
| Month 2 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | month 2 (28 days) |
| Month 3 Responder Rate | Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
| month 3 (28 days) |
| Month 1 Responder Rate | Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
| month 1 (28 days) |
| Month 2 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 2 |
| Month 3 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 3 |
| Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Any bowel movement not associated with rescue medication use | Change from baseline for month 2 |
| Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Any bowel movement not associated with rescue medication use | Change from baseline for month 3 |
| Month 2 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | Change from baseline for month 2 |
| Month 3 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | Change from baseline for month 3 |
| Month 2 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 2 |
| Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 3 |
| Month 2 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 2 |
| Month 3 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 3 |
| Month 2 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | Change from baseline for month 2 |
| Month 3 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | Change from baseline for month 3 |
| Month 1 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 1 |
| Month 1 Bowel Movement Frequency Rates Change From Baseline | Change from baseline for month 1 |
| Month 2 Bowel Movement Frequency Rates Change From Baseline | Change from baseline for month 2 |
| Month 3 Bowel Movement Frequency Rates Change From Baseline | Change from baseline for month 3 |
| Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 1 |
| Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 2 |
| Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Change from baseline for month 3 |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Inches |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Month 1 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 1 |
|
|
|
|
| Secondary | Month 1 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 1 |
|
|
|
|
| Secondary | Month 1 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline at 28 days |
|
|
|
|
| Secondary | Month 1 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 1 |
|
|
|
|
| Secondary | Quality of Life Change From Baseline | Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase | ITT without LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline at 12 weeks |
|
|
|
|
| Primary | Overall Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months | Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF) | Posted | Number | percentage of participants | 12 weeks |
|
|
|
|
| Secondary | Month 2 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | ITT without LOCF | Posted | Number | percent of participants | month 2 (28 days) |
|
|
|
|
| Secondary | Month 3 Responder Rate | Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
| ITT without LOCF | Posted | Number | percent of participants | month 3 (28 days) |
|
|
|
|
| Secondary | Month 1 Responder Rate | Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
| ITT without LOCF | Posted | Number | percent of participants | month 1 (28 days) |
|
|
|
|
| Secondary | Month 2 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 3 |
|
|
|
|
| Secondary | Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Any bowel movement not associated with rescue medication use | ITT with LOCF | Posted | Mean | Standard Deviation | SBM/week | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Any bowel movement not associated with rescue medication use | ITT with LOCF | Posted | Mean | Standard Deviation | SBM/week | Change from baseline for month 3 |
|
|
|
|
| Secondary | Month 2 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 3 |
|
|
|
|
| Secondary | Month 2 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 3 |
|
|
|
|
| Secondary | Month 2 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 3 |
|
|
|
|
| Secondary | Month 2 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 2 |
|
|
|
|
| Secondary | Month 3 Symptom Relief | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 3 |
|
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|
|
| Secondary | Month 1 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | Scale score | Change from baseline for month 1 |
|
|
|
|
| Secondary | Month 1 Bowel Movement Frequency Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | BM/week | Change from baseline for month 1 |
|
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|
| Secondary | Month 2 Bowel Movement Frequency Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | BM/week | Change from baseline for month 2 |
|
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|
| Secondary | Month 3 Bowel Movement Frequency Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | BM/week | Change from baseline for month 3 |
|
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|
|
| Secondary | Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Posted | Mean | Standard Deviation | Scale Score | Change from baseline for month 1 |
|
|
|
|
| Secondary | Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Posted | Mean | Standard Deviation | Scale Score | Change from baseline for month 2 |
|
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|
|
| Secondary | Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | Posted | Mean | Standard Deviation | Scale Score | Change from baseline for month 3 |
|
|
|
|
| 5 |
| 396 |
| 75 |
| EG001 | Placebo Study Period I | Matching placebo capsules twice daily (BID) | 2 | 192 | 25 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
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| D008055 |
| Lipids |