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The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1500 mg IW-3718 BID | Experimental | Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
|
| Placebo | Placebo Comparator | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-3718 | Drug | oral tablet |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WHSS at Week 8 | The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | The WRFS is defined as the average of available daily regurgitation frequency scores (DRFS) during a week. DRFS is defined as the maximum score of the 2 items measuring regurgitation from a particular day (Item #6 "Regurgitation [liquid or food moving upwards toward your throat or mouth]" and Item #7 "An acid or bitter taste in the mouth"). The DRFS items are assessed on a 4-point ordinal scale, where 0=Never, 1=Rarely, 2-Sometimes, 3=Often, and 4=Very Often; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. |
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Inclusion Criteria:
Each patient must meet all of the following criteria to be eligible for enrollment in this study:
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the study:
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Shetzline, MD, PhD | Ironwood Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Digestive Health Specialists of The Southeast |
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After the screening and pre-treatment periods, participants were stratified by whether they had/did not have erosive esophagitis (EE) on esophagogastroduodenoscopy (EGD), and by their baseline weekly heartburn severity score (WHSS, defined as the average heartburn severity score over the last 7 days prior to randomization of < 3 vs. ≥ 3), and were randomly assigned 1:1 within each stratum to placebo or 1500 mg IW-3718 twice daily (BID).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo BID + PPIs | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose proton pump inhibitors (PPIs) administered once-daily (QD) approximately 30-60 minutes before the morning meal each day. |
| FG001 | 1500 mg IW-3718 BID + PPIs |
| 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 | Yes | No | No | Study Protocol | Jul 20, 2020 | Jul 23, 2021 |
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| Drug |
oral tablet |
|
| Standard-dose PPIs QD | Drug | background therapy |
|
| Baseline, Week 8 |
| Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of >/= 45% from baseline in WHSS. A participant who reported heartburn severity for less than 4 days during a week is not considered a responder for that week. The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement | Up to Week 8 |
| Proportion of Heartburn-Free Days During the 8-Week Treatment Period | Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement | Up to Week 8 |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Holland Center for Family Health | Peoria | Arizona | 85381 | United States |
| Hope Research Institute LLC | Peoria | Arizona | 85381 | United States |
| Atria Clinical Research | Little Rock | Arkansas | 72209 | United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Hope Clinical Research, LLC | Canoga Park | California | 91303 | United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| Torrance Clinical Research | Lomita | California | 90717 | United States |
| United Gastroenterologists | Murrieta | California | 92563 | United States |
| Clinical Applications Laboratories Inc | San Diego | California | 92103 | United States |
| Care Access Research, San Pablo | San Pablo | California | 94806 | United States |
| Paragon Rx Clinical, Inc. - Santa Ana | Santa Ana | California | 92703 | United States |
| Medical Research Center of Connecticut LLC | Hamden | Connecticut | 06518 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Optimus U Corp | Coral Gables | Florida | 33134 | United States |
| Nature Coast Clinical Research LLC - ERN-PPDS | Inverness | Florida | 34452 | United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32207 | United States |
| Precision Clinical Research, LLC | Lauderdale Lakes | Florida | 33319 | United States |
| Suncoast Research Group LLC - ERN-PPDS | Miami | Florida | 33135 | United States |
| Applemed Research Inc | Miami | Florida | 33155 | United States |
| Gutierrez Medical Center | Orlando | Florida | 32807 | United States |
| Columbus Regional Research Institute at Talbotton | Columbus | Georgia | 31904 | United States |
| Consultative Gastroenterology | Decatur | Georgia | 30034 | United States |
| Atlanta Center For Clinical Research | Roswell | Georgia | 30075 | United States |
| Clinical Research Atlanta - ERN-PPDS | Stockbridge | Georgia | 30281 | United States |
| IL Gastroenterology Group | Gurnee | Illinois | 60041 | United States |
| Edward Hines Jr VA Hospital - NAVREF | Hines | Illinois | 60141 | United States |
| Aquiant Research | New Albany | Indiana | 47150 | United States |
| Kansas Medical Clinic | Topeka | Kansas | 66606 | United States |
| Heartland Research Associates LLC | Wichita | Kansas | 67207 | United States |
| Gastroenterology Associates LLC | Baton Rouge | Louisiana | 70809 | United States |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | United States |
| Clinical Trials of America LA LLC | West Monroe | Louisiana | 71291 | United States |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Commonwealth Clinical Studies LLC | Brockton | Massachusetts | 02302 | United States |
| Center For Digestive Health | Troy | Michigan | 48098 | United States |
| Gastroenterology Associates of West Michigan | Wyoming | Michigan | 49519 | United States |
| Gastroenterology Associates of Western Michigan, PLC | Wyoming | Michigan | 49519 | United States |
| Gastrointestinal Associates PA | Flowood | Mississippi | 39232 | United States |
| Kansas City VA Medical Center - NAVREF | Kansas City | Missouri | 64128 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Digestive Disease Specialists | Las Vegas | Nevada | 89128 | United States |
| Office of Michael Zimmerman, MD | Las Vegas | Nevada | 89128 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| NYScientific | Brooklyn | New York | 11235 | United States |
| Long Island Gastrointestinal Research Group LLP | Great Neck | New York | 11023 | United States |
| United Health Services Hospitals | Johnson City | New York | 13790 | United States |
| Syracuse VA Medical Center - NAVREF | Syracuse | New York | 13210 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| Asheville Gastroenterology Associates PA | Asheville | North Carolina | 28801 | United States |
| UNC Medical Center | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | United States |
| Clinical Trials of America-NC, LLC | Mount Airy | North Carolina | 27030 | United States |
| PMG Research of Salisbury LLC | Salisbury | North Carolina | 28144 | United States |
| Trial Management Associates LLC | Wilmington | North Carolina | 28403 | United States |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Remington Davis Inc | Columbus | Ohio | 43214 | United States |
| Dayton Gastroenterology Inc | Dayton | Ohio | 45440 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Lynn Health Science Institute - ERN-PPDS | Oklahoma City | Oklahoma | 73112 | United States |
| Northwest Gastroenterology Clinic | Portland | Oregon | 97210 | United States |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | United States |
| Guthrie Research Institute | Sayre | Pennsylvania | 18840 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Clinical Trials of South Carolina - ClinEdge - PPDS | Charleston | South Carolina | 29406 | United States |
| Pharmacorp Clinical Trials Incorporated | Charleston | South Carolina | 29412 | United States |
| Gastroenterology Associates, PA | Greenville | South Carolina | 29615 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Trials of South Carolina | North Charleston | South Carolina | 29406 | United States |
| Franklin Gastroenterology | Franklin | Tennessee | 37067 | United States |
| Clinical Research Solutions PC | Jackson | Tennessee | 38305 | United States |
| QUALITY Medical Research - Interspond - PPDS | Nashville | Tennessee | 37211 | United States |
| Inquest Clinical Research | Baytown | Texas | 77521 | United States |
| Texas Health Physicians Group | Carrollton | Texas | 75007 | United States |
| Northside Gastroenterology | Cypress | Texas | 77429 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Kelsey Research Foundation | Houston | Texas | 77025 | United States |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | United States |
| Coastal Medical Group | Houston | Texas | 77089 | United States |
| San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC) | San Antonio | Texas | 78229 | United States |
| Care Access Research | Salt Lake City | Utah | 84124 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132-2101 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132-2101 | United States |
| Advanced Clinical Research - Gut Whisperer- ERN-PPDS | West Jordan | Utah | 84088 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| The Gastroenterology Group | Reston | Virginia | 22191 | United States |
| Clinical Research Partners LLC | Richmond | Virginia | 23220 | United States |
| Clinical Research Partners LLC | Richmond | Virginia | 23235 | United States |
| Aurora Medical Center Summit | Summit | Wisconsin | 53066 | United States |
| Aurora Health Care | Waukesha | Wisconsin | 53186 | United States |
| Hughie Fraser, MD | Bridgewater | Nova Scotia | B4V 3K9 | Canada |
| Viable Clinical Research | Bridgewater | Nova Scotia | B4V 3K9 | Canada |
| Toronto Digestive Disease Associates Inc | Vaughan | Ontario | L4L 4Y7 | Canada |
Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: Participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo BID + PPIs | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| BG001 | 1500 mg IW-3718 BID + PPIs | Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Erosive Esophagitis (EE) | Modified Intent-to-Treat (mITT) Population, which included all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Count of Participants | Participants |
| |||||||||||||||
| Weekly Heartburn Severity Score (WHSS) Category | WHSS=weekly average of Daily Heartburn Severity Score (DHSS). DHSS=the greater of the 2 items assessing heartburn severity (#1=Burning feeling behind the breastbone or in the center of the upper stomach; #2=Pain behind the breastbone or in the center of the upper stomach), where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. Baseline is derived from the daily eDiary data collected in the pretreatment period, specifically the period of time from 7 days before randomization up to the time of randomization. | mITT Population, which included all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Count of Participants | Participants |
| ||||||||||||||
| WHSS | WHSS=weekly average of DHSS. DHSS=the greater of the 2 items assessing heartburn severity (#1=Burning feeling behind the breastbone or in the center of the upper stomach; #2=Pain behind the breastbone or in the center of the upper stomach), where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. Baseline is derived from the daily eDiary data collected in the pretreatment period, specifically the period of time from 7 days before randomization up to the time of randomization. | mITT Population, which included all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Mean | Standard Deviation | score on a scale |
|
| 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 WHSS at Week 8 | The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 | The WRFS is defined as the average of available daily regurgitation frequency scores (DRFS) during a week. DRFS is defined as the maximum score of the 2 items measuring regurgitation from a particular day (Item #6 "Regurgitation [liquid or food moving upwards toward your throat or mouth]" and Item #7 "An acid or bitter taste in the mouth"). The DRFS items are assessed on a 4-point ordinal scale, where 0=Never, 1=Rarely, 2-Sometimes, 3=Often, and 4=Very Often; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 8 |
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| Secondary | Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period | An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of >/= 45% from baseline in WHSS. A participant who reported heartburn severity for less than 4 days during a week is not considered a responder for that week. The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement | Modified Intent-to-Treat (mITT) Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Posted | Number | percentage of participants | Up to Week 8 |
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| Secondary | Proportion of Heartburn-Free Days During the 8-Week Treatment Period | Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement | mITT Population: all participants who 1) were randomized prior to or on 05 June 2020, 2) had received at least 1 dose of study drug, and 3) had at least 1 postbaseline primary efficacy assessment. | Posted | Mean | Standard Error | proportion of days | Up to Week 8 |
|
From first dose of study drug through the end of treatment (up to Week 8) plus 7 days.
Safety Population: Participants who received at least 1 dose of study drug.
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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 | Placebo BID + PPIs | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day. | 1 | 304 | 3 | 304 | 6 | 304 |
| EG001 | 1500 mg IW-3718 BID + PPIs | Three IW-3718 tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day. | 0 | 304 | 2 | 304 | 15 | 304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulseless electrical activity | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ironwood Study Chair | Ironwood Pharmaceuticals, Inc. | (617) 621-7722 | Info@ironwoodpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2020 | Jul 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
|
|
| Not Hispanic or Latino |
|
|
| Unknown |
|
|
| Not Reported |
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| Other |
|
|
|
| EE Not Present |
|
|
|
| WHSS Score < 3 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 1500 mg IW-3718 BID + PPIs |
Three 500 mg IW-3718 tablets administered BID, immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before morning meal each day. |
|
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|
|
|
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