Trial Outcomes & Findings for A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD) (NCT NCT02637557)
NCT ID: NCT02637557
Last Updated: 2019-10-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Placebo BID
Matching placebo twice daily (BID)
|
500 mg IW-3718 BID
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
71
|
69
|
|
Overall Study
COMPLETED
|
63
|
66
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
9
|
7
|
Reasons for withdrawal
| Measure |
Placebo BID
Matching placebo twice daily (BID)
|
500 mg IW-3718 BID
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
2
|
Baseline Characteristics
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Baseline characteristics by cohort
| Measure |
Placebo BID
n=70 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
50.1 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Weekly Heartburn Severity Score (WHSS)
|
3.18 score on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
3.19 score on a scale
STANDARD_DEVIATION 0.72 • n=7 Participants
|
3.12 score on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
3.19 score on a scale
STANDARD_DEVIATION 0.71 • n=4 Participants
|
3.17 score on a scale
STANDARD_DEVIATION 0.68 • n=21 Participants
|
|
Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
|
3.08 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
3.01 units on a scale
STANDARD_DEVIATION 0.66 • n=7 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
3.08 units on a scale
STANDARD_DEVIATION 0.66 • n=4 Participants
|
3.04 units on a scale
STANDARD_DEVIATION 0.65 • n=21 Participants
|
|
mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
|
2.85 units on a scale
STANDARD_DEVIATION 0.82 • n=5 Participants
|
2.91 units on a scale
STANDARD_DEVIATION 0.82 • n=7 Participants
|
2.77 units on a scale
STANDARD_DEVIATION 0.82 • n=5 Participants
|
2.98 units on a scale
STANDARD_DEVIATION 0.78 • n=4 Participants
|
2.88 units on a scale
STANDARD_DEVIATION 0.81 • n=21 Participants
|
|
mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
|
2.73 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
2.80 units on a scale
STANDARD_DEVIATION 0.89 • n=7 Participants
|
2.57 units on a scale
STANDARD_DEVIATION 0.95 • n=5 Participants
|
2.85 units on a scale
STANDARD_DEVIATION 0.91 • n=4 Participants
|
2.74 units on a scale
STANDARD_DEVIATION 0.91 • n=21 Participants
|
|
mRESQ-eD Item 'Difficulty Swallowing Severity'
|
1.71 units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
1.81 units on a scale
STANDARD_DEVIATION 1.27 • n=7 Participants
|
2.15 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
2.05 units on a scale
STANDARD_DEVIATION 1.17 • n=4 Participants
|
1.93 units on a scale
STANDARD_DEVIATION 1.23 • n=21 Participants
|
|
mRESQ-eD Item 'Hoarseness Severity'
|
1.75 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
1.81 units on a scale
STANDARD_DEVIATION 1.31 • n=7 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
|
1.81 units on a scale
STANDARD_DEVIATION 1.31 • n=4 Participants
|
1.84 units on a scale
STANDARD_DEVIATION 1.29 • n=21 Participants
|
|
mRESQ-eD Item 'Cough Severity'
|
1.78 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 1.26 • n=7 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
2.16 units on a scale
STANDARD_DEVIATION 1.22 • n=4 Participants
|
2.07 units on a scale
STANDARD_DEVIATION 1.25 • n=21 Participants
|
|
mRESQ-eD Item 'Regurgitation Frequency'
|
2.03 units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
2.29 units on a scale
STANDARD_DEVIATION 0.80 • n=7 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 0.88 • n=4 Participants
|
2.15 units on a scale
STANDARD_DEVIATION 0.92 • n=21 Participants
|
|
mRESQ-eD Item 'Acid or Bitter Taste Frequency'
|
2.09 units on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants
|
2.25 units on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 0.98 • n=5 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 1.01 • n=4 Participants
|
2.18 units on a scale
STANDARD_DEVIATION 0.98 • n=21 Participants
|
|
mRESQ-eD Item 'Coughing Frequency'
|
1.65 units on a scale
STANDARD_DEVIATION 1.10 • n=5 Participants
|
1.91 units on a scale
STANDARD_DEVIATION 1.06 • n=7 Participants
|
1.96 units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
1.96 units on a scale
STANDARD_DEVIATION 1.00 • n=4 Participants
|
1.87 units on a scale
STANDARD_DEVIATION 1.04 • n=21 Participants
|
|
mRESQ-eD Item 'Burping Frequency'
|
2.26 units on a scale
STANDARD_DEVIATION 1.04 • n=5 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 0.91 • n=7 Participants
|
2.33 units on a scale
STANDARD_DEVIATION 0.85 • n=5 Participants
|
2.51 units on a scale
STANDARD_DEVIATION 0.90 • n=4 Participants
|
2.33 units on a scale
STANDARD_DEVIATION 0.93 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
|
-46.026 percentage change in score
Standard Error 4.078
|
-48.978 percentage change in score
Standard Error 4.019
|
-55.063 percentage change in score
Standard Error 4.024
|
-57.969 percentage change in score
Standard Error 4.108
|
SECONDARY outcome
Timeframe: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Percent Change From Baseline to Week 4 in WHSS
|
-38.883 percentage change in score
Standard Error 3.733
|
-42.594 percentage change in score
Standard Error 3.679
|
-41.622 percentage change in score
Standard Error 3.683
|
-47.486 percentage change in score
Standard Error 3.761
|
SECONDARY outcome
Timeframe: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in WHSS
|
-1.459 score on a scale
Standard Error 0.129
|
-1.517 score on a scale
Standard Error 0.127
|
-1.713 score on a scale
Standard Error 0.127
|
-1.876 score on a scale
Standard Error 0.130
|
SECONDARY outcome
Timeframe: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline to Week 4 in WHSS
|
-1.261 score on a scale
Standard Error 0.115
|
-1.313 score on a scale
Standard Error 0.113
|
-1.308 score on a scale
Standard Error 0.113
|
-1.517 score on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Week 8Population: modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment
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.
Outcome measures
| Measure |
Placebo BID
n=70 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Overall Heartburn Responders
|
54.3 percentage of participants
Interval 41.9 to 66.3
|
52.1 percentage of participants
Interval 39.9 to 64.1
|
62.0 percentage of participants
Interval 49.7 to 73.2
|
66.2 percentage of participants
Interval 53.7 to 77.2
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=70 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8
|
28.6 percentage of participants
Interval 18.4 to 40.6
|
18.3 percentage of participants
Interval 10.1 to 29.3
|
29.6 percentage of participants
Interval 19.3 to 41.6
|
38.2 percentage of participants
Interval 26.7 to 50.8
|
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=70 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4
|
12.9 percentage of participants
Interval 6.1 to 23.0
|
15.5 percentage of participants
Interval 8.0 to 26.0
|
22.5 percentage of participants
Interval 13.5 to 34.0
|
22.1 percentage of participants
Interval 12.9 to 33.8
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=62 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=66 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=63 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=62 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8
|
2.998 days
Standard Error 0.358
|
2.700 days
Standard Error 0.347
|
3.250 days
Standard Error 0.355
|
3.510 days
Standard Error 0.359
|
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=64 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=70 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=67 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4
|
2.275 days
Standard Error 0.336
|
2.294 days
Standard Error 0.322
|
2.694 days
Standard Error 0.329
|
2.736 days
Standard Error 0.327
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 1
|
-0.655 units on a scale
Standard Error 0.090
|
-0.632 units on a scale
Standard Error 0.089
|
-0.531 units on a scale
Standard Error 0.089
|
-0.673 units on a scale
Standard Error 0.091
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 2
|
-0.994 units on a scale
Standard Error 0.102
|
-0.974 units on a scale
Standard Error 0.101
|
-0.977 units on a scale
Standard Error 0.101
|
-1.102 units on a scale
Standard Error 0.103
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 3
|
-1.092 units on a scale
Standard Error 0.109
|
-1.141 units on a scale
Standard Error 0.107
|
-1.153 units on a scale
Standard Error 0.107
|
-1.350 units on a scale
Standard Error 0.109
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 4
|
-1.263 units on a scale
Standard Error 0.112
|
-1.281 units on a scale
Standard Error 0.110
|
-1.259 units on a scale
Standard Error 0.110
|
-1.498 units on a scale
Standard Error 0.112
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 5
|
-1.284 units on a scale
Standard Error 0.120
|
-1.301 units on a scale
Standard Error 0.119
|
-1.339 units on a scale
Standard Error 0.119
|
-1.677 units on a scale
Standard Error 0.121
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 6
|
-1.396 units on a scale
Standard Error 0.121
|
-1.343 units on a scale
Standard Error 0.119
|
-1.467 units on a scale
Standard Error 0.119
|
-1.744 units on a scale
Standard Error 0.122
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 7
|
-1.392 units on a scale
Standard Error 0.127
|
-1.350 units on a scale
Standard Error 0.125
|
-1.436 units on a scale
Standard Error 0.125
|
-1.693 units on a scale
Standard Error 0.128
|
|
Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'
Week 8
|
-1.404 units on a scale
Standard Error 0.127
|
-1.482 units on a scale
Standard Error 0.126
|
-1.666 units on a scale
Standard Error 0.126
|
-1.807 units on a scale
Standard Error 0.128
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 1
|
-0.638 units on a scale
Standard Error 0.089
|
-0.536 units on a scale
Standard Error 0.087
|
-0.492 units on a scale
Standard Error 0.088
|
-0.675 units on a scale
Standard Error 0.089
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 2
|
-0.998 units on a scale
Standard Error 0.103
|
-0.918 units on a scale
Standard Error 0.101
|
-0.970 units on a scale
Standard Error 0.102
|
-1.116 units on a scale
Standard Error 0.104
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 3
|
-1.040 units on a scale
Standard Error 0.108
|
-1.074 units on a scale
Standard Error 0.106
|
-1.112 units on a scale
Standard Error 0.107
|
-1.385 units on a scale
Standard Error 0.109
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 4
|
-1.199 units on a scale
Standard Error 0.113
|
-1.246 units on a scale
Standard Error 0.112
|
-1.316 units on a scale
Standard Error 0.112
|
-1.497 units on a scale
Standard Error 0.114
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 5
|
-1.226 units on a scale
Standard Error 0.120
|
-1.287 units on a scale
Standard Error 0.118
|
-1.323 units on a scale
Standard Error 0.118
|
-1.648 units on a scale
Standard Error 0.121
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 6
|
-1.357 units on a scale
Standard Error 0.119
|
-1.297 units on a scale
Standard Error 0.117
|
-1.450 units on a scale
Standard Error 0.117
|
-1.733 units on a scale
Standard Error 0.120
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 7
|
-1.310 units on a scale
Standard Error 0.124
|
-1.359 units on a scale
Standard Error 0.122
|
-1.424 units on a scale
Standard Error 0.122
|
-1.676 units on a scale
Standard Error 0.125
|
|
Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'
Week 8
|
-1.329 units on a scale
Standard Error 0.122
|
-1.422 units on a scale
Standard Error 0.120
|
-1.627 units on a scale
Standard Error 0.121
|
-1.781 units on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 1
|
-0.602 units on a scale
Standard Error 0.089
|
-0.548 units on a scale
Standard Error 0.088
|
-0.454 units on a scale
Standard Error 0.089
|
-0.626 units on a scale
Standard Error 0.090
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 2
|
-0.921 units on a scale
Standard Error 0.103
|
-0.869 units on a scale
Standard Error 0.101
|
-0.934 units on a scale
Standard Error 0.102
|
-1.083 units on a scale
Standard Error 0.103
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 3
|
-1.002 units on a scale
Standard Error 0.110
|
-1.008 units on a scale
Standard Error 0.108
|
-1.126 units on a scale
Standard Error 0.109
|
-1.313 units on a scale
Standard Error 0.111
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 4
|
-1.185 units on a scale
Standard Error 0.113
|
-1.210 units on a scale
Standard Error 0.111
|
-1.244 units on a scale
Standard Error 0.112
|
-1.439 units on a scale
Standard Error 0.114
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 5
|
-1.279 units on a scale
Standard Error 0.119
|
-1.230 units on a scale
Standard Error 0.117
|
-1.299 units on a scale
Standard Error 0.118
|
-1.578 units on a scale
Standard Error 0.120
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 6
|
-1.343 units on a scale
Standard Error 0.118
|
-1.257 units on a scale
Standard Error 0.117
|
-1.367 units on a scale
Standard Error 0.117
|
-1.665 units on a scale
Standard Error 0.119
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 7
|
-1.252 units on a scale
Standard Error 0.122
|
-1.303 units on a scale
Standard Error 0.121
|
-1.302 units on a scale
Standard Error 0.121
|
-1.638 units on a scale
Standard Error 0.124
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'
Week 8
|
-1.289 units on a scale
Standard Error 0.121
|
-1.333 units on a scale
Standard Error 0.119
|
-1.525 units on a scale
Standard Error 0.119
|
-1.674 units on a scale
Standard Error 0.122
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 1
|
-0.498 units on a scale
Standard Error 0.075
|
-0.405 units on a scale
Standard Error 0.074
|
-0.309 units on a scale
Standard Error 0.074
|
-0.519 units on a scale
Standard Error 0.076
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 2
|
-0.618 units on a scale
Standard Error 0.088
|
-0.566 units on a scale
Standard Error 0.086
|
-0.611 units on a scale
Standard Error 0.087
|
-0.714 units on a scale
Standard Error 0.088
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 3
|
-0.671 units on a scale
Standard Error 0.094
|
-0.675 units on a scale
Standard Error 0.092
|
-0.817 units on a scale
Standard Error 0.092
|
-1.022 units on a scale
Standard Error 0.094
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 4
|
-0.737 units on a scale
Standard Error 0.098
|
-0.763 units on a scale
Standard Error 0.096
|
-0.810 units on a scale
Standard Error 0.096
|
-1.061 units on a scale
Standard Error 0.098
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 5
|
-0.824 units on a scale
Standard Error 0.098
|
-0.850 units on a scale
Standard Error 0.096
|
-0.846 units on a scale
Standard Error 0.096
|
-1.156 units on a scale
Standard Error 0.098
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 6
|
-0.883 units on a scale
Standard Error 0.102
|
-0.805 units on a scale
Standard Error 0.100
|
-0.961 units on a scale
Standard Error 0.100
|
-1.174 units on a scale
Standard Error 0.102
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 7
|
-0.849 units on a scale
Standard Error 0.107
|
-0.756 units on a scale
Standard Error 0.105
|
-0.906 units on a scale
Standard Error 0.106
|
-1.166 units on a scale
Standard Error 0.108
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'
Week 8
|
-0.864 units on a scale
Standard Error 0.107
|
-0.822 units on a scale
Standard Error 0.105
|
-0.989 units on a scale
Standard Error 0.105
|
-1.197 units on a scale
Standard Error 0.107
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 1
|
-0.329 units on a scale
Standard Error 0.074
|
-0.292 units on a scale
Standard Error 0.073
|
-0.400 units on a scale
Standard Error 0.073
|
-0.406 units on a scale
Standard Error 0.074
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 2
|
-0.483 units on a scale
Standard Error 0.090
|
-0.416 units on a scale
Standard Error 0.089
|
-0.605 units on a scale
Standard Error 0.089
|
-0.544 units on a scale
Standard Error 0.091
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 3
|
-0.526 units on a scale
Standard Error 0.095
|
-0.574 units on a scale
Standard Error 0.094
|
-0.796 units on a scale
Standard Error 0.094
|
-0.778 units on a scale
Standard Error 0.096
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 4
|
-0.505 units on a scale
Standard Error 0.102
|
-0.631 units on a scale
Standard Error 0.101
|
-0.842 units on a scale
Standard Error 0.101
|
-0.833 units on a scale
Standard Error 0.103
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 5
|
-0.588 units on a scale
Standard Error 0.107
|
-0.684 units on a scale
Standard Error 0.106
|
-0.870 units on a scale
Standard Error 0.106
|
-0.842 units on a scale
Standard Error 0.108
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 6
|
-0.617 units on a scale
Standard Error 0.110
|
-0.677 units on a scale
Standard Error 0.108
|
-0.990 units on a scale
Standard Error 0.108
|
-0.962 units on a scale
Standard Error 0.110
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 7
|
-0.570 units on a scale
Standard Error 0.111
|
-0.626 units on a scale
Standard Error 0.109
|
-0.860 units on a scale
Standard Error 0.109
|
-1.054 units on a scale
Standard Error 0.111
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'
Week 8
|
-0.604 units on a scale
Standard Error 0.108
|
-0.683 units on a scale
Standard Error 0.107
|
-0.954 units on a scale
Standard Error 0.107
|
-1.086 units on a scale
Standard Error 0.109
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 8
|
-0.613 units on a scale
Standard Error 0.107
|
-0.706 units on a scale
Standard Error 0.105
|
-0.949 units on a scale
Standard Error 0.105
|
-1.158 units on a scale
Standard Error 0.107
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 1
|
-0.426 units on a scale
Standard Error 0.078
|
-0.283 units on a scale
Standard Error 0.076
|
-0.353 units on a scale
Standard Error 0.076
|
-0.389 units on a scale
Standard Error 0.078
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 2
|
-0.574 units on a scale
Standard Error 0.095
|
-0.501 units on a scale
Standard Error 0.093
|
-0.608 units on a scale
Standard Error 0.093
|
-0.589 units on a scale
Standard Error 0.095
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 3
|
-0.534 units on a scale
Standard Error 0.092
|
-0.614 units on a scale
Standard Error 0.090
|
-0.745 units on a scale
Standard Error 0.090
|
-0.890 units on a scale
Standard Error 0.092
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 4
|
-0.530 units on a scale
Standard Error 0.099
|
-0.657 units on a scale
Standard Error 0.097
|
-0.878 units on a scale
Standard Error 0.097
|
-0.914 units on a scale
Standard Error 0.099
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 5
|
-0.616 units on a scale
Standard Error 0.106
|
-0.692 units on a scale
Standard Error 0.104
|
-0.840 units on a scale
Standard Error 0.104
|
-0.972 units on a scale
Standard Error 0.107
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 6
|
-0.634 units on a scale
Standard Error 0.107
|
-0.671 units on a scale
Standard Error 0.105
|
-0.953 units on a scale
Standard Error 0.105
|
-1.026 units on a scale
Standard Error 0.107
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'
Week 7
|
-0.594 units on a scale
Standard Error 0.112
|
-0.688 units on a scale
Standard Error 0.110
|
-0.971 units on a scale
Standard Error 0.110
|
-1.063 units on a scale
Standard Error 0.112
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 1
|
-0.483 units on a scale
Standard Error 0.067
|
-0.385 units on a scale
Standard Error 0.066
|
-0.340 units on a scale
Standard Error 0.066
|
-0.511 units on a scale
Standard Error 0.068
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 2
|
-0.647 units on a scale
Standard Error 0.082
|
-0.637 units on a scale
Standard Error 0.081
|
-0.597 units on a scale
Standard Error 0.081
|
-0.774 units on a scale
Standard Error 0.083
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 3
|
-0.581 units on a scale
Standard Error 0.084
|
-0.784 units on a scale
Standard Error 0.083
|
-0.791 units on a scale
Standard Error 0.083
|
-0.879 units on a scale
Standard Error 0.085
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 4
|
-0.769 units on a scale
Standard Error 0.089
|
-0.855 units on a scale
Standard Error 0.088
|
-0.838 units on a scale
Standard Error 0.087
|
-0.984 units on a scale
Standard Error 0.089
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 5
|
-0.758 units on a scale
Standard Error 0.087
|
-0.869 units on a scale
Standard Error 0.086
|
-0.866 units on a scale
Standard Error 0.085
|
-1.028 units on a scale
Standard Error 0.087
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 6
|
-0.834 units on a scale
Standard Error 0.090
|
-0.936 units on a scale
Standard Error 0.089
|
-0.939 units on a scale
Standard Error 0.089
|
-1.093 units on a scale
Standard Error 0.090
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 7
|
-0.796 units on a scale
Standard Error 0.090
|
-0.899 units on a scale
Standard Error 0.089
|
-0.867 units on a scale
Standard Error 0.089
|
-1.081 units on a scale
Standard Error 0.091
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'
Week 8
|
-0.811 units on a scale
Standard Error 0.092
|
-0.951 units on a scale
Standard Error 0.091
|
-1.029 units on a scale
Standard Error 0.091
|
-1.191 units on a scale
Standard Error 0.093
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 1
|
-0.502 units on a scale
Standard Error 0.069
|
-0.374 units on a scale
Standard Error 0.068
|
-0.401 units on a scale
Standard Error 0.068
|
-0.530 units on a scale
Standard Error 0.070
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 2
|
-0.738 units on a scale
Standard Error 0.084
|
-0.640 units on a scale
Standard Error 0.082
|
-0.676 units on a scale
Standard Error 0.082
|
-0.784 units on a scale
Standard Error 0.084
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 3
|
-0.691 units on a scale
Standard Error 0.082
|
-0.806 units on a scale
Standard Error 0.081
|
-0.842 units on a scale
Standard Error 0.081
|
-0.874 units on a scale
Standard Error 0.083
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 4
|
-0.797 units on a scale
Standard Error 0.090
|
-0.847 units on a scale
Standard Error 0.088
|
-0.893 units on a scale
Standard Error 0.088
|
-0.952 units on a scale
Standard Error 0.090
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 5
|
-0.868 units on a scale
Standard Error 0.089
|
-0.920 units on a scale
Standard Error 0.087
|
-0.929 units on a scale
Standard Error 0.087
|
-1.024 units on a scale
Standard Error 0.089
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 6
|
-0.870 units on a scale
Standard Error 0.092
|
-0.966 units on a scale
Standard Error 0.091
|
-1.009 units on a scale
Standard Error 0.091
|
-1.098 units on a scale
Standard Error 0.093
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 7
|
-0.895 units on a scale
Standard Error 0.094
|
-0.912 units on a scale
Standard Error 0.092
|
-0.947 units on a scale
Standard Error 0.092
|
-1.053 units on a scale
Standard Error 0.094
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'
Week 8
|
-0.896 units on a scale
Standard Error 0.094
|
-0.938 units on a scale
Standard Error 0.093
|
-1.072 units on a scale
Standard Error 0.093
|
-1.163 units on a scale
Standard Error 0.095
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 1
|
-0.374 units on a scale
Standard Error 0.064
|
-0.286 units on a scale
Standard Error 0.063
|
-0.290 units on a scale
Standard Error 0.063
|
-0.352 units on a scale
Standard Error 0.064
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 2
|
-0.572 units on a scale
Standard Error 0.081
|
-0.469 units on a scale
Standard Error 0.079
|
-0.484 units on a scale
Standard Error 0.079
|
-0.571 units on a scale
Standard Error 0.081
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 3
|
-0.477 units on a scale
Standard Error 0.083
|
-0.605 units on a scale
Standard Error 0.081
|
-0.594 units on a scale
Standard Error 0.081
|
-0.729 units on a scale
Standard Error 0.083
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 5
|
-0.506 units on a scale
Standard Error 0.095
|
-0.659 units on a scale
Standard Error 0.093
|
-0.648 units on a scale
Standard Error 0.093
|
-0.812 units on a scale
Standard Error 0.095
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 6
|
-0.594 units on a scale
Standard Error 0.092
|
-0.653 units on a scale
Standard Error 0.090
|
-0.700 units on a scale
Standard Error 0.090
|
-0.872 units on a scale
Standard Error 0.092
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 7
|
-0.561 units on a scale
Standard Error 0.097
|
-0.656 units on a scale
Standard Error 0.095
|
-0.713 units on a scale
Standard Error 0.095
|
-0.872 units on a scale
Standard Error 0.097
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 8
|
-0.554 units on a scale
Standard Error 0.095
|
-0.647 units on a scale
Standard Error 0.093
|
-0.718 units on a scale
Standard Error 0.093
|
-0.988 units on a scale
Standard Error 0.095
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'
Week 4
|
-0.497 units on a scale
Standard Error 0.089
|
-0.667 units on a scale
Standard Error 0.087
|
-0.685 units on a scale
Standard Error 0.087
|
-0.793 units on a scale
Standard Error 0.089
|
SECONDARY outcome
Timeframe: 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, 8Population: 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.
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.
Outcome measures
| Measure |
Placebo BID
n=69 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=71 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 1
|
-0.459 units on a scale
Standard Error 0.071
|
-0.416 units on a scale
Standard Error 0.070
|
-0.309 units on a scale
Standard Error 0.070
|
-0.416 units on a scale
Standard Error 0.071
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 2
|
-0.669 units on a scale
Standard Error 0.083
|
-0.649 units on a scale
Standard Error 0.082
|
-0.556 units on a scale
Standard Error 0.082
|
-0.614 units on a scale
Standard Error 0.084
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 3
|
-0.605 units on a scale
Standard Error 0.085
|
-0.705 units on a scale
Standard Error 0.084
|
-0.734 units on a scale
Standard Error 0.084
|
-0.754 units on a scale
Standard Error 0.086
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 4
|
-0.701 units on a scale
Standard Error 0.092
|
-0.794 units on a scale
Standard Error 0.091
|
-0.797 units on a scale
Standard Error 0.090
|
-0.866 units on a scale
Standard Error 0.093
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 5
|
-0.744 units on a scale
Standard Error 0.091
|
-0.832 units on a scale
Standard Error 0.090
|
-0.813 units on a scale
Standard Error 0.090
|
-0.910 units on a scale
Standard Error 0.092
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 6
|
-0.801 units on a scale
Standard Error 0.094
|
-0.845 units on a scale
Standard Error 0.093
|
-0.845 units on a scale
Standard Error 0.093
|
-0.942 units on a scale
Standard Error 0.095
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 7
|
-0.810 units on a scale
Standard Error 0.099
|
-0.896 units on a scale
Standard Error 0.098
|
-0.803 units on a scale
Standard Error 0.097
|
-0.909 units on a scale
Standard Error 0.100
|
|
Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'
Week 8
|
-0.809 units on a scale
Standard Error 0.102
|
-0.973 units on a scale
Standard Error 0.101
|
-0.920 units on a scale
Standard Error 0.100
|
-1.008 units on a scale
Standard Error 0.103
|
SECONDARY outcome
Timeframe: Week 8Population: modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.
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.
Outcome measures
| Measure |
Placebo BID
n=61 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=66 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=62 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=62 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline in the Proportion of Heartburn-Free Days During Week 8
|
0.276 proportion of days
Standard Error 0.049
|
0.256 proportion of days
Standard Error 0.047
|
0.310 proportion of days
Standard Error 0.049
|
0.347 proportion of days
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Week 4Population: modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.
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.
Outcome measures
| Measure |
Placebo BID
n=64 Participants
Matching placebo BID
|
500 mg IW-3718 BID
n=70 Participants
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=66 Participants
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 Participants
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Change From Baseline in the Proportion of Heartburn-Free Days During Week 4
|
0.141 proportion of days
Standard Error 0.037
|
0.142 proportion of days
Standard Error 0.035
|
0.134 proportion of days
Standard Error 0.036
|
0.241 proportion of days
Standard Error 0.036
|
Adverse Events
Placebo BID
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
500 mg IW-3718 BID
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
1000 mg IW-3718 BID
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
1500 mg IW-3718 BID
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo BID
n=70 participants at risk
Matching placebo BID
|
500 mg IW-3718 BID
n=71 participants at risk
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 participants at risk
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 participants at risk
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/70 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/71 • 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.
|
1.5%
1/68 • 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.
|
|
General disorders
Chest pain
|
0.00%
0/70 • 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.
|
0.00%
0/71 • 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.
|
1.4%
1/71 • 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.
|
0.00%
0/68 • 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.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/70 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/68 • 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.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/68 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/70 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/71 • 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.
|
1.5%
1/68 • 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.
|
|
Surgical and medical procedures
Selective abortion
|
0.00%
0/70 • 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.
|
1.4%
1/71 • 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.
|
0.00%
0/71 • 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.
|
0.00%
0/68 • 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.
|
Other adverse events
| Measure |
Placebo BID
n=70 participants at risk
Matching placebo BID
|
500 mg IW-3718 BID
n=71 participants at risk
500 mg IW-3718 BID
|
1000 mg IW-3718 BID
n=71 participants at risk
1000 mg IW-3718 BID
|
1500 mg IW-3718 BID
n=68 participants at risk
1500 mg IW-3718 BID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.1%
5/70 • 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.
|
8.5%
6/71 • 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.
|
8.5%
6/71 • 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.
|
7.4%
5/68 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • 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.
|
4.2%
3/71 • 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.
|
5.6%
4/71 • 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.
|
8.8%
6/68 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
3/70 • 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.
|
9.9%
7/71 • 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.
|
5.6%
4/71 • 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.
|
1.5%
1/68 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
4/70 • 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.
|
2.8%
2/71 • 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.
|
5.6%
4/71 • 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.
|
2.9%
2/68 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
5/70 • 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.
|
2.8%
2/71 • 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.
|
4.2%
3/71 • 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.
|
4.4%
3/68 • 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.
|
|
Psychiatric disorders
Insomnia
|
7.1%
5/70 • 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.
|
0.00%
0/71 • 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.
|
1.4%
1/71 • 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.
|
0.00%
0/68 • 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.
|
Additional Information
IW-3718-202 Study Chair
Ironwood Pharmaceuticals, Inc.
Phone: 1 (617) 621-7722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER