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| Name | Class |
|---|---|
| Sucampo Pharmaceuticals, Inc. | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Responder Status | Overall responder: monthly responder for at least 2 out of 3 months Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Month 1 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days |
| Month 1 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Sucampo Pharmaceuticals, Inc. | Study Director |
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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 enrolled 05/19/05; last subject observed 08/02/06, at 65 centers across the US
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | Subjects who received active drug |
| FG001 | Placebo | Subjects who received placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | Subjects who received active drug |
| BG001 | Placebo | 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Responder Status | Overall responder: monthly responder for at least 2 out of 3 months Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | Intention to treat (ITT), without Last Observational Carried Forward (LOCF). | Posted | Number | percentage of participants | 12 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 | Subjects who received active drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast 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 | |
|---|---|---|---|---|
| Raymond Panas, PhD | Sucampo Pharmaceuticals, Inc. | 301-961-3400 | info@sucampo.com |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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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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| 28 days |
| Month 1 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 1 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 1 Symptom Relief |
| 28 days |
| Month 1 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | 28 days |
| 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; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | 28 days |
| Month 3 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. | 28 days |
| Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 1 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 2 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 3 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 2 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days |
| Month 3 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days |
| Month 2 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days |
| Month 3 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days |
| Month 2 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 2 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 3 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days |
| Month 2 Symptom Relief |
| 28 days |
| Month 3 Symptom Relief |
| 28 days |
| Month 3 Quality of Life Change From Baseline | 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 | 12 weeks |
| Month 1 Bowel Movement Rates Change From Baseline | 28 days |
| Month 2 Bowel Movement Rates Change From Baseline | 28 days |
| Month 3 Bowel Movement Rates Change From Baseline | 28 days |
| Withdrawal by Subject |
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| Lack of Efficacy |
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| Lost to Follow-up |
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| Other |
|
| Physician Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
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| Secondary | Month 1 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | ITT with LOCF | Posted | Mean | Standard Deviation | spontaneous bowel movements (SBMs)/week | 28 days |
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| 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 | units on a scale | 28 days |
|
|
|
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| 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 | units on a scale | 28 days |
|
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|
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| 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 | units on a scale | 28 days |
|
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|
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| Secondary | Month 1 Symptom Relief |
| ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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| Secondary | Month 1 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient 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 | percentage of participants | 28 days |
|
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| 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; AND patient 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 | percentage of participants | 28 days |
|
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|
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| Secondary | Month 3 Responder Rate | Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient 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 | percentage of participants | 28 days |
|
|
|
|
| Secondary | Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
|
|
|
| Secondary | Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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|
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| Secondary | Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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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 | units on a scale | 28 days |
|
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|
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| 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 | units on a scale | 28 days |
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| 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 | units on a scale | 28 days |
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| Secondary | Month 2 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | ITT with LOCF | Posted | Mean | Standard Deviation | SBMs/week | 28 days |
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| Secondary | Month 3 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | ITT with LOCF | Posted | Mean | Standard Deviation | SBMs/week | 28 days |
|
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|
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| 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 | units on a scale | 28 days |
|
|
|
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| 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 | units on a scale | 28 days |
|
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|
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| 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 | units on a scale | 28 days |
|
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|
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| Secondary | Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
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| 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 | units on a scale | 28 days |
|
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|
| 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 | units on a scale | 28 days |
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| Secondary | Month 2 Symptom Relief |
| ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
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| Secondary | Month 3 Symptom Relief |
| ITT with LOCF | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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| Secondary | Month 3 Quality of Life Change From Baseline | 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 | units on a scale | 12 weeks |
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| Secondary | Month 1 Bowel Movement Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | bowel movements (BMs)/week | 28 days |
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| Secondary | Month 2 Bowel Movement Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | BMs/week | 28 days |
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| Secondary | Month 3 Bowel Movement Rates Change From Baseline | ITT, with LOCF | Posted | Mean | Standard Deviation | BMs/week | 28 days |
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| 2 |
| 67 |
| EG001 | Placebo | Subjects who received placebo | 2 | 30 |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Small intestine gangrene | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |