| ID | Type | Description | Link |
|---|---|---|---|
| MSA-NC-LUB-125 | Other Grant/Funding Number | Takeda Pharmaceuticals |
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The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubrication.
Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.
Specific Aim 1. To test the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).
Specific Aim 2. To explore the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).
Specific Aim 3. To address the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).
Specific Aim 4. To test the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).
Specific Aim 5. To explore the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (secondary outcome).
Specific Aim 6. To address the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (secondary outcome).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone 24 mcg Twice a day | Active Comparator | Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo. |
|
| Placebo | Placebo Comparator | Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lubiprostone | Drug | 24mcg twice a day (BID) 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). | Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). | Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. |
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Asymptomatic Volunteers:
Inclusion Criteria:
Exclusion Criteria:
Patients with Chronic Constipation:
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jerzy Sarosiek, MD, PhD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
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Patients interested in our study were interviewed and examined 1 week before the 1st assigned after randomization medication was administered for one week of therapy.
Subsequently, when patients finished their first week of medication, they had one week as of wash-out before the 2nd therapy in this cross-over design of our study protocol.
During an entire recruitment time all patients signed their consent forms and participate in the study protocol within the specially designated clinical research room at Texas Tech University Health Sciences Center(TTUHSC), El Paso.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo | Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo. lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week |
| FG001 | Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone | Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone. placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week |
| FG002 | Controls on Lubiprostone Then Placebo | Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week |
| FG003 | Controls on Placebo Then Lubiprostone | Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone. placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period for 1 Week |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo | Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). | Number of participants was calculated to provide statistical power of 0.80 for detection of significance. | Posted | Mean | Standard Error | mg/hour | Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. |
|
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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 | Chronic Constipation Subjects on Lubiprostone Then Placebo | Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerzy Sarosiek, Director, Mol. Medicine Research | TexasTech | 915-215-5255 | jerzy.sarosiek@ttuhsc.edu |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| placebo | Drug | Placebo pills twice a day for one week. |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone |
Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone. placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week |
| BG002 | Controls on Lubiprostone Then Placebo | Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week |
| BG003 | Controls on Placebo Then Lubiprostone | Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design |
|
|
| Secondary | Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). | To provide 0.80 statistical power for detection of significance. | Posted | Mean | Standard Error | Centipoises | Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Chronic Constipation Subjects on Placebo Then Lubiprostone | Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone. | 0 | 10 | 0 | 10 |
| EG002 | Controls on Lubiprostone Then Placebo | Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo. | 0 | 10 | 0 | 10 |
| EG003 | Controls on Placebo Then Lubiprostone | Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone. | 0 | 10 | 0 | 10 |
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| D008055 |
| Lipids |
| Pentagastrin-Stimulated viscosity in CC |
|
| Pentagastrin-Stimulated viscosity in Controls |
|