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| Name | Class |
|---|---|
| Gelesis, Inc. | INDUSTRY |
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Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSP01 | Experimental | Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. |
|
| Carboxymethylcellulose (CMC) | Active Comparator | Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. |
|
| Placebo | Placebo Comparator | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSP01 | Device | Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Colonic Transit Time (CTT) | Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT. | Up to 1 week; measured once during the run-in-period and again during third week of the treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Average number of Complete Spontaneous Bowel Movements per day (BMs where participant felt that they emptied their bowels). More CSBMs are interpreted as a better outcome. | 55 days (baseline, treatment, & follow-up) |
| Stool Consistency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Staller, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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52 patients signed the consent form and thus were considered enrolled. 4 failed screening 48 passed screening
5 withdrew before run-in
1 lost to follow-up 42 started run-in
2 failed run-in 40 randomized
1 withdrew due to AE 39 completed study
1 patient's follow-up CTT data irretrievable (technical malfunction) 38 complete CTTs
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| ID | Title | Description |
|---|---|---|
| FG000 | CSP01 | Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2017 |
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| Carboxymethylcellulose (CMC) | Device | Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
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| Placebo | Device | Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
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Stool consistency for each bowel movement based on the Bristol Stool Scale A descriptive numerical scale from 1 to 7 where lower numbers indicate constipation, numbers toward the middle indicate normal stool consistence, and the highest numbers indicate diarrhea. Therefore middle scores mean a better outcome 1= hard lumps 2 = lumpy sausage 3 = cracked sausage 4 = smooth sausage 5 = soft lumps 6 = mushy 7 = watery |
| 55 days (baseline, treatment, & follow-up) |
| Ease of Passage Rating | Patient assessment of the ease with which bowel movements are passed using a descriptive numerical scale where lower numbers indicate difficult passage of stool, numbers toward the middle indicate more normal passage of stool, and numbers on the highest end indicate abnormally urgent passage of stool. Middle scores indicate a better outcome.
| 55 days (baseline, treatment, & follow-up) |
| Patient's Assessment of Abdominal Discomfort | Patient's daily assessment of abdominal discomfort using a numerical rating scale of 0 to 10, where 0 = no discomfort at all and 10 = severe discomfort. Higher scores mean a worse outcome. | 55 days (baseline, treatment, & follow-up) |
| Patient Assessment of Bloating Severity | Patient's daily assessment of bloating severity using a numerical rating scale from 0 to 10 where 0 = no bloating at all and 10 = severe bloating. Higher scores mean a worse outcome. | 55 days (baseline, treatment, & follow-up) |
| Patient Assessment of Constipation Severity | Patient's daily assessment of constipation severity using a numerical rating scale from 0 to 10 where 0 = no constipation at all and 10 = severe constipation. Higher numbers mean a worse outcome. | 55 days (baseline, treatment, & follow-up) |
| Relief Rating | Patient's feeling of overall relief after each bowel movement using a numerical rating scale from 0 to 10 where 0 = no relief and 10 = complete relief. Higher scores mean a better outcome (feeling more relief after a bowel movement). | 55 days (baseline, treatment, & follow-up) |
| Patient Assessment of Constipation - Symptoms (PAC-SYM) | Patient assessment of constipation symptom severity questionnaire. A validated 12-question questionnaire. Numerical scale from 0 to 4 where 0 = absent and 4 = very severe. Possible total score ranges from 0 to 48. Higher total PAC-SYM scores mean a worse outcome. PAC-SYM was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment. | Day -14 to Day 22 |
| Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Patient Assessment of Constipation Quality of Life Questionnaire. A validated questionnaire containing 28 total questions with four sub-sections each broadly ranging from "not at all" to "all of the time" on 0 to 4 scales. Possible total range is 0 to 112. An overall higher total score on the PAC-QOL means a worse outcome. PAC-QOL was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment. | Day -14 to Day 22 |
| Need for Rescue Laxatives | Number of total days that rescue laxatives were used by participants in each treatment group. (The number of days that rescue laxatives were used by each individual patient was calculated and added to the treatment group total) | 55 days (baseline, treatment, & follow-up) |
| Spontaneous Bowel Movement (SBM) Frequency | Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements) | 55 days (baseline, treatment, & follow-up) |
| FG001 | Carboxymethylcellulose (CMC) | Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| FG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CSP01 | Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| BG001 | Carboxymethylcellulose (CMC) | Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| BG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diagnosis: CIC, IBS-C | Count of Participants | 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 From Baseline in Colonic Transit Time (CTT) | Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT. | All participants who completed the study. (39 participants) Note: One participant who received placebo had pre-treatment CTT data, but post-treatment CTT data was irretrievable due to technical malfunction. This subject's pre-treatment CTT data is included in analysis, but no post-treatment CTT data. | Posted | Mean | Standard Deviation | minutes | Up to 1 week; measured once during the run-in-period and again during third week of the treatment period |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Complete Spontaneous Bowel Movement (CSBM) Frequency Rate | Average number of Complete Spontaneous Bowel Movements per day (BMs where participant felt that they emptied their bowels). More CSBMs are interpreted as a better outcome. | All participants who completed the study and had both pre and post treatment CSBM measurement | Posted | Mean | Standard Deviation | number of CSBMs per day | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Stool Consistency | Stool consistency for each bowel movement based on the Bristol Stool Scale A descriptive numerical scale from 1 to 7 where lower numbers indicate constipation, numbers toward the middle indicate normal stool consistence, and the highest numbers indicate diarrhea. Therefore middle scores mean a better outcome 1= hard lumps 2 = lumpy sausage 3 = cracked sausage 4 = smooth sausage 5 = soft lumps 6 = mushy 7 = watery | All participants who completed the study and had both pre and post treatment stool consistency ratings. | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Ease of Passage Rating | Patient assessment of the ease with which bowel movements are passed using a descriptive numerical scale where lower numbers indicate difficult passage of stool, numbers toward the middle indicate more normal passage of stool, and numbers on the highest end indicate abnormally urgent passage of stool. Middle scores indicate a better outcome.
| All participants who completed the study and had both pre and post treatment ease of passage ratings | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient's Assessment of Abdominal Discomfort | Patient's daily assessment of abdominal discomfort using a numerical rating scale of 0 to 10, where 0 = no discomfort at all and 10 = severe discomfort. Higher scores mean a worse outcome. | All participants who completed the study and had both pre and post treatment abdominal discomfort ratings | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Assessment of Bloating Severity | Patient's daily assessment of bloating severity using a numerical rating scale from 0 to 10 where 0 = no bloating at all and 10 = severe bloating. Higher scores mean a worse outcome. | All participants who completed the study and had both pre and post treatment bloating ratings. | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Assessment of Constipation Severity | Patient's daily assessment of constipation severity using a numerical rating scale from 0 to 10 where 0 = no constipation at all and 10 = severe constipation. Higher numbers mean a worse outcome. | All participants who completed the study and had both pre and post treatment constipation severity ratings | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Relief Rating | Patient's feeling of overall relief after each bowel movement using a numerical rating scale from 0 to 10 where 0 = no relief and 10 = complete relief. Higher scores mean a better outcome (feeling more relief after a bowel movement). | All participants who completed the study and had both pre and post treatment relief ratings | Posted | Mean | Standard Deviation | score on a scale | 55 days (baseline, treatment, & follow-up) |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Assessment of Constipation - Symptoms (PAC-SYM) | Patient assessment of constipation symptom severity questionnaire. A validated 12-question questionnaire. Numerical scale from 0 to 4 where 0 = absent and 4 = very severe. Possible total score ranges from 0 to 48. Higher total PAC-SYM scores mean a worse outcome. PAC-SYM was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment. | All participants who completed the study and had both pre and post treatment PAC-SYM ratings | Posted | Mean | Standard Deviation | score on a scale | Day -14 to Day 22 |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Assessment of Constipation - Quality of Life (PAC-QOL) | Patient Assessment of Constipation Quality of Life Questionnaire. A validated questionnaire containing 28 total questions with four sub-sections each broadly ranging from "not at all" to "all of the time" on 0 to 4 scales. Possible total range is 0 to 112. An overall higher total score on the PAC-QOL means a worse outcome. PAC-QOL was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment. | All participants who completed the study and had both pre and post treatment PAC-QOL ratings | Posted | Mean | Standard Deviation | score on a scale | Day -14 to Day 22 |
| |||||||||||||||||||||||||||||||||
| Secondary | Need for Rescue Laxatives | Number of total days that rescue laxatives were used by participants in each treatment group. (The number of days that rescue laxatives were used by each individual patient was calculated and added to the treatment group total) | All participants who completed the study and had daily medication usage data | Posted | Number | days | 55 days (baseline, treatment, & follow-up) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Spontaneous Bowel Movement (SBM) Frequency | Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements) | All participants who completed the study and had both pre and post treatment SBM measurements | Posted | Mean | Standard Deviation | number of SBMs per day | 55 days (baseline, treatment, & follow-up) |
|
Adverse event data was collected for each subject throughout the study duration, from study enrollment to final day in study (includes 9-day follow-up period). Study duration was approximately 46-59 days.
All participants of the study were assessed for adverse events throughout the duration of the study. Adverse events were recorded, logged, and reported to the IRB where applicable. In-person follow-up was arranged for participants experiencing an adverse event to monitor resolution of symptoms.
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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 | CSP01 | Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. CSP01: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG001 | Carboxymethylcellulose (CMC) | Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation and back pain caused by constipation | Gastrointestinal disorders | Systematic Assessment | Subject experienced several bowel movements per day coupled with a sense of urgency, but never able to have a complete bowel movement. Subject also developed back pain attributed to constipation. |
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Target number of participants needed to achieve target power was not attained. One subject's post-treatment SmartPill data was irretrievable due to unexpected technical malfunction, therefore post-treatment colonic transit time was not collected.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Staller | Massachusetts General Hospital | 617-726-3080 | kstaller@mgh.harvard.edu |
| Mar 11, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2017 | Mar 11, 2019 | ICF_001.pdf |
| 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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| Between 18 and 65 years |
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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 |
|
| Unknown or Not Reported |
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| Irritable Bowel Syndrome with Constipation |
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| OG002 |
| Placebo |
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
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| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
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| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
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| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
| OG002 |
| Placebo |
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
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| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.
Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Carboxymethylcellulose (CMC): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
| OG002 | Placebo | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
| OG002 |
| Placebo |
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
|
|
| Placebo |
Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Placebo: Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. |
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