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The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Matching placebo twice daily |
|
| 500 mg IW-3718 | Experimental | 500 mg IW-3718 twice daily |
|
| 1000 mg IW-3718 | Experimental | 1000 mg IW-3718 twice daily |
|
| 1500 mg IW-3718 | Experimental | 1500 mg IW-3718 twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-3718 | Drug |
| ||
| Matching Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 4 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Additional inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Lara Lane | Ironwood Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IW-3718 Investigator | Dothan | Alabama | 36305 | United States | ||
| IW-3718 Investigator |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32092310 | Derived | Vaezi MF, Fass R, Vakil N, Reasner DS, Mittleman RS, Hall M, Shao JZ, Chen Y, Lane L, Gates AM, Currie MG. IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial. Gastroenterology. 2020 Jun;158(8):2093-2103. doi: 10.1053/j.gastro.2020.02.031. Epub 2020 Feb 22. | |
| 31977454 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo BID | Matching placebo twice daily (BID) |
| FG001 | 500 mg IW-3718 BID | 500 mg IW-3718 BID |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2017 | Sep 21, 2019 |
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| Drug |
|
| PPI | Drug | All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study. |
|
| Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4 |
| Change From Baseline to Week 8 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8 |
| Change From Baseline to Week 4 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4 |
| Percentage of Participants Who Are Overall Heartburn Responders | 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 >= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | Week 8 |
| Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | Week 8 |
| Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | Week 4 |
| Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | Week 8 |
| Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | Week 4 |
| Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
| Change From Baseline in the Proportion of Heartburn-Free Days During Week 8 | A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | Week 8 |
| Change From Baseline in the Proportion of Heartburn-Free Days During Week 4 | A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | Week 4 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| IW-3718 Investigator | Tucson | Arizona | 85710 | United States |
| IW-3718 Investigator | Tucson | Arizona | 85712 | United States |
| IW-3718 Investigator | Tucson | Arizona | 85741 | United States |
| IW-3718 Investigator | North Little Rock | Arkansas | 72117 | United States |
| IW-3718 Investigator | Anaheim | California | 92801 | United States |
| IW-3718 Investigator | Carmichael | California | 95608 | United States |
| IW-3718 Investigator | Chula Vista | California | 91910 | United States |
| IW-3718 Investigator | La Mirada | California | 90638 | United States |
| IW-3718 Investigator | Mission Hills | California | 91345 | United States |
| IW-3718 Investigator | Newport Beach | California | 92660 | United States |
| IW-3718 Investigator | Oakland | California | 94612 | United States |
| IW-3718 Investigator | Sacramento | California | 95821 | United States |
| IW-3718 Investigator | San Diego | California | 92123 | United States |
| IW-3718 Investigator | Bristol | Connecticut | 06010 | United States |
| IW-3718 Investigator | Waterbury | Connecticut | 06708 | United States |
| IW-3718 Investigator | DeLand | Florida | 32720 | United States |
| IW-3718 Investigator | Hollywood | Florida | 33024 | United States |
| IW-3718 Investigator | Inverness | Florida | 34452 | United States |
| IW-3718 Investigator | Jupiter | Florida | 33458 | United States |
| IW-3718 Investigator | Lauderdale Lakes | Florida | 33319 | United States |
| IW-3718 Investigator | Miami | Florida | 33126 | United States |
| IW-3718 Investigator | Miami | Florida | 33135 | United States |
| IW-3718 Investigator | Miami Lakes | Florida | 33014 | United States |
| IW-3718 Investigator | Port Orange | Florida | 32129 | United States |
| IW-3718 Investigator | Clive | Iowa | 50325 | United States |
| IW-3718 Investigator | Bowling Green | Kentucky | 42101 | United States |
| IW-3718 Investigator | Monroe | Louisiana | 71201 | United States |
| IW-3718 Investigator | Annapolis | Maryland | 21401 | United States |
| IW-3718 Investigator | Baltimore | Maryland | 21215 | United States |
| IW-3718 Investigator | Chevy Chase | Maryland | 20815 | United States |
| IW-3718 Investigator | Chesterfield | Michigan | 48047 | United States |
| IW-3718 Investigator | Wyoming | Michigan | 49519 | United States |
| IW-3718 Investigator | Las Vegas | Nevada | 89128 | United States |
| IW-3718 Investigator | Reno | Nevada | 89511 | United States |
| IW-3718 Investigator | Egg Harbor | New Jersey | 08234 | United States |
| IW-3718 Investigator | Great Neck | New York | 11021 | United States |
| IW-3718 Investigator | Great Neck | New York | 11023 | United States |
| IW-3718 Investigator | Kew Gardens | New York | 11415 | United States |
| IW-3718 Investigator | New York | New York | 10065 | United States |
| IW-3718 Investigator | Asheville | North Carolina | 28801 | United States |
| IW-3718 Investigator | Raleigh | North Carolina | 27612 | United States |
| IW-3718 Investigator | Fargo | North Dakota | 58103 | United States |
| IW-3718 Investigator | Cleveland | Ohio | 44109 | United States |
| IW-3718 Investigator | Columbus | Ohio | 43213 | United States |
| IW-3718 Investigator | Lima | Ohio | 45806 | United States |
| IW-3718 Investigator | Norman | Oklahoma | 73071 | United States |
| IW-3718 Investigator | Oklahoma City | Oklahoma | 73104 | United States |
| IW-3718 Investigator | Pittsburgh | Pennsylvania | 15243 | United States |
| IW-3718 Investigator | Charleston | South Carolina | 29412 | United States |
| IW-3718 Investigator | Chattanooga | Tennessee | 37421 | United States |
| IW-3718 Investigator | Germantown | Tennessee | 38138 | United States |
| IW-3718 Investigator | Nashville | Tennessee | 37232 | United States |
| IW-3718 Investigator | El Paso | Texas | 79905 | United States |
| IW-3718 Investigator | Houston | Texas | 77098 | United States |
| IW-3718 Investigator | San Antonio | Texas | 78209 | United States |
| IW-3718 Investigator | San Antonio | Texas | 78229 | United States |
| IW-3718 Investigator | Sandy City | Utah | 84092 | United States |
| IW-3718 Investigator | South Ogden | Utah | 84405 | United States |
| IW-3718 Investigator | Christiansburg | Virginia | 24073 | United States |
| IW-3718 Investigator | Lynchburg | Virginia | 24502 | United States |
| Andrae DA, Hanlon J, Cala ML, Scippa K, Graham C, Witherspoon B, Shao JZ, Reasner D. Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00117. doi: 10.14309/ctg.0000000000000117. |
| FG002 |
| 1000 mg IW-3718 BID |
1000 mg IW-3718 BID |
| FG003 | 1500 mg IW-3718 BID | 1500 mg IW-3718 BID |
| COMPLETED |
|
| NOT COMPLETED |
|
|
modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo BID | Matching placebo BID |
| BG001 | 500 mg IW-3718 BID | 500 mg IW-3718 BID |
| BG002 | 1000 mg IW-3718 BID | 1000 mg IW-3718 BID |
| BG003 | 1500 mg IW-3718 BID | 1500 mg IW-3718 BID |
| BG004 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weekly Heartburn Severity Score (WHSS) | The WHSS for an analysis week was defined as the average of available Daily Heartburn Severity Scale (DHSS) during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ("Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach") from a particular day. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Difficulty Swallowing Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Hoarseness Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Cough Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Regurgitation Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Acid or Bitter Taste Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Coughing Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| mRESQ-eD Item 'Burping Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Baseline was derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization. | Mean | Standard Deviation | units 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 | Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period. | Posted | Least Squares Mean | Standard Error | percentage change in score | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8 |
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| Secondary | Percent Change From Baseline to Week 4 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period. | Posted | Least Squares Mean | Standard Error | percentage change in score | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4 |
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| Secondary | Change From Baseline to Week 8 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8 |
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| Secondary | Change From Baseline to Week 4 in WHSS | The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4 |
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| Secondary | Percentage of Participants Who Are Overall Heartburn Responders | 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 >= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and given treatment week. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and given treatment week. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | days | Week 8 |
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| Secondary | Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4 | DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | days | Week 4 |
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| Secondary | Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency' | The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8 |
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| Secondary | Change From Baseline in the Proportion of Heartburn-Free Days During Week 8 | A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week. | Posted | Least Squares Mean | Standard Error | proportion of days | Week 8 |
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| Secondary | Change From Baseline in the Proportion of Heartburn-Free Days During Week 4 | A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. | modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week. | Posted | Least Squares Mean | Standard Error | proportion of days | Week 4 |
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From the first dose of study drug through Week 8/End-of-treatment (Day 57 + 3 days) plus 7 days.
Treatment-emergent adverse events (TEAEs) are presented. TEAEs are defined as adverse events (AEs) that started after the first dose of study drug or started before the first dose of study drug but increased in severity after the first dose of study drug. Safety population: all participants who were randomized and received at least 1 dose of study drug.
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 | Placebo BID | Matching placebo BID | 0 | 70 | 2 | 70 | 16 | 70 |
| EG001 | 500 mg IW-3718 BID | 500 mg IW-3718 BID | 0 | 71 | 1 | 71 | 17 | 71 |
| EG002 | 1000 mg IW-3718 BID | 1000 mg IW-3718 BID | 0 | 71 | 1 | 71 | 19 | 71 |
| EG003 | 1500 mg IW-3718 BID | 1500 mg IW-3718 BID | 0 | 68 | 2 | 68 | 12 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
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| Selective abortion | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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All data generated in this study will be the property of Ironwood. Publication of the results by the Principal Investigator will be subject to mutual agreement between the Investigator and Ironwood.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IW-3718-202 Study Chair | Ironwood Pharmaceuticals, Inc. | 1 (617) 621-7722 | Info@ironwoodpharma.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 27, 2016 | Oct 14, 2019 | Prot_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
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Caucasian |
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| Other, Not Specified |
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| ANCOVA |
| 0.1160 |
P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate. |
| LS Mean Difference |
| -9.036 |
| 2-Sided |
| 95 |
| -20.318 |
| 2.245 |
| Superiority |
| ANCOVA | 0.0400 | P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate. | LS Mean Difference | -11.943 | 2-Sided | 95 | -23.334 | -0.551 | Superiority |
| trend test | 0.0225 | Dose trend test performed using linear contrast statement. | Superiority |
| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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| OG003 | 1500 mg IW-3718 BID | 1500 mg IW-3718 BID |
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| OG003 |
| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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| 1500 mg IW-3718 BID |
1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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1500 mg IW-3718 BID |
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