Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lubiprostone | Drug | lubiprostone 24 microgram capsule taken twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Spontaneous Bowel Movements Per Week | 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Constipation Symptoms | The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine E. O'Brien, Pharm.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | 24 micrograms twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | 24 micrograms twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The number of subjects analyzed here is 7 as only 7 completed this pilot study. |
| 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 Spontaneous Bowel Movements Per Week | Participants who completed the study | Posted | Mean | Standard Deviation | bowel movements | 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubiprostone | 24 micrograms twice daily |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine O'Brien | University of Arkansas for Medical Sciences | 501-364-1828 | obriencatherinee@uams.edu |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment |
| Bristol Stool Scale Score | The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea. | 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment |
| Body Mass Index | baseline, 2 weeks of treatment, 4 weeks of treatment |
| Self Reported Adverse Effects at Each Study Visit | Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit. | During entire study period |
| Serum Sodium | baseline, 4 weeks |
| Serum Chloride | baseline and 4 weeks |
| Serum Potassium | baseline and 4 weeks |
| Serum Bicarb | baseline and 4 weeks |
| Serum BUN | baseline and 4 weeks |
| Serum Creatinine | baseline and 4 weeks |
| AST | baseline and 4 weeks |
| ALT | baseline and 4 weeks |
| Serum Calcium | baseline and 4 weeks |
| Serum Magnesium | baseline and 4 weeks |
| Serum Phosphate | baseline and 4 weeks |
| Serum Glucose | baseline and 4 weeks |
| Serum Vitamin D | baseline and 4 weeks |
| Serum Vitamin A | baseline and 4 weeks |
| Serum Vitamin E | baseline and 4 weeks |
| Serum Prealbumin | baseline and 4 weeks |
| Serum Albumin | baseline and 4 weeks |
| Count of Participants |
| Participants |
|
| Age Continuous | The number of subjects analyzed here is 7 as only 7 completed this pilot study. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The number of subjects analyzed here is 7 as only 7 completed this pilot study. | Count of Participants | Participants |
|
| Region of Enrollment | The number of subjects analyzed here is 7 as only 7 completed this pilot study. | Number | participants |
|
|
| Secondary | Patient Assessment of Constipation Symptoms | The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4). | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment |
|
|
|
| Secondary | Bristol Stool Scale Score | The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea. | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment |
|
|
|
| Secondary | Body Mass Index | Participants who completed the study | Posted | Mean | Standard Deviation | kg/m^2 | baseline, 2 weeks of treatment, 4 weeks of treatment |
|
|
|
| Secondary | Self Reported Adverse Effects at Each Study Visit | Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit. | Participants who completed the study | Posted | Number | participants | During entire study period |
|
|
|
| Secondary | Serum Sodium | Participants who completed the study | Posted | Mean | Standard Deviation | nmol/L | baseline, 4 weeks |
|
|
|
| Secondary | Serum Chloride | Participants who completed the study | Posted | Mean | Standard Deviation | nmol/L | baseline and 4 weeks |
|
|
|
| Secondary | Serum Potassium | Participants who completed the study | Posted | Mean | Standard Deviation | nmol/L | baseline and 4 weeks |
|
|
|
| Secondary | Serum Bicarb | Participants who completed the study | Posted | Mean | Standard Deviation | nmol/L | baseline and 4 weeks |
|
|
|
| Secondary | Serum BUN | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Creatinine | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | AST | Participants who completed the study | Posted | Mean | Standard Deviation | U/L | baseline and 4 weeks |
|
|
|
| Secondary | ALT | Participants who completed the study | Posted | Mean | Standard Deviation | U/L | baseline and 4 weeks |
|
|
|
| Secondary | Serum Calcium | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Magnesium | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Phosphate | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Glucose | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Vitamin D | Participants who completed the study | Posted | Mean | Standard Deviation | ng/mL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Vitamin A | Participants who completed the study | Posted | Mean | Standard Deviation | ug/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Vitamin E | Participants who completed the study | Posted | Mean | Standard Deviation | mg/L | baseline and 4 weeks |
|
|
|
| Secondary | Serum Prealbumin | Participants who completed the study | Posted | Mean | Standard Deviation | mg/dL | baseline and 4 weeks |
|
|
|
| Secondary | Serum Albumin | Participants who completed the study | Posted | Mean | Standard Deviation | g/dL | baseline and 4 weeks |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| Abdominal bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal cramping | Gastrointestinal disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Migraine | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Transient chest tightness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D008055 |
| Lipids |
| Title | Measurements |
|---|---|
|
| Title |
|---|
| Measurements |
|---|
|