Trial Outcomes & Findings for A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole (NCT NCT05055128)
NCT ID: NCT05055128
Last Updated: 2023-11-01
Results Overview
The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
248 participants
Primary outcome timeframe
Week 4
Results posted on
2023-11-01
Participant Flow
This study was conducted at 36 centers which included 248 patients across 08 countries. The trial began on 11 Aug 2021 (first patient enrolled) and was completed on 01 Sep 2022 (Last patient completed).
The pre-treatment assessments were performed during the screening period (Day -7 to Day 0) prior to the first dose preferably. All the study assessments were performed as per the schedule of assessments.
Participant milestones
| Measure |
X842 25 mg BID
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
52
|
47
|
50
|
|
Overall Study
COMPLETED
|
45
|
45
|
50
|
41
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
2
|
6
|
3
|
Reasons for withdrawal
| Measure |
X842 25 mg BID
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
2
|
4
|
2
|
|
Overall Study
Randomized By Mistake
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
Baseline characteristics by cohort
| Measure |
X842 25 mg BID
n=51 Participants
Patients received 2 tablets (X842 25 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=48 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=52 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=47 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=50 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.7 Years
STANDARD_DEVIATION 15.99 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
54.8 Years
STANDARD_DEVIATION 13.26 • n=4 Participants
|
49.1 Years
STANDARD_DEVIATION 15.41 • n=21 Participants
|
49.3 Years
STANDARD_DEVIATION 14.81 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
152 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
242 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
247 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. FAS erosive is a subset of FAS consisted of patients who had been classified as erosive (Grade A, B, C or D) as screening according to the central reading or imputed by local reading if missing.
The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
Outcome measures
| Measure |
X842 25 mg BID
n=38 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=37 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=41 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=33 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=33 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Number of Patients With Esophageal Mucosa Healing
|
28 Participants
|
28 Participants
|
32 Participants
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From Screening (Day -7 to Day 0) until Week 8Population: The safety analysis set consisted of all patients who had been randomized and received at least 1 dose of study drug. Patients were analyzed according to the treatment actually received.
The safety and tolerability of the four dose levels of X842 and Lansoprazole were evaluated, where Lansoprazole served as the active comparator. Here TEAE- Treatment-emergent adverse event, ADR- Adverse drug reaction, SAE- Serious adverse event, and AESI- Adverse events of special interest.
Outcome measures
| Measure |
X842 25 mg BID
n=51 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=48 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=52 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=47 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=50 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Number of Patients With Adverse Events (AEs)
Any treatment emergent AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any AE
|
15 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any TEAE
|
14 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any severe TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any treatment related TEAE (ADR)
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any TEAE leading to study discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any SAE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
Any Serious TEAE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1 and 8Population: The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the "Number Analyzed" in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week.
Heartburn-free in a 24-hour day was a day where patient reported having no burning feeling or pain behind breast or in center of upper stomach for both morning and evening. Percentage of heartburn-free 24-hour days based on eDiary(Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with four dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks Lansoprazole treatment in open-label. Modified RESQ-eDiary was validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains \[i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max:0-15) and Regurgitations/Reflux (min-max: 0-8)\]. Endoscopy followed by lansoprazole administration and symptom evaluation using PRO QOLRAD (Heartburn version) and patient diaries assessed acid control achieved with X842 at 4 weeks.
Outcome measures
| Measure |
X842 25 mg BID
n=48 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=46 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=51 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=46 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=48 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Heartburn-Free 24-hour Days
Week 1
|
27.0 Percentage of days
Standard Error 5.80
|
25.1 Percentage of days
Standard Error 5.91
|
29.2 Percentage of days
Standard Error 5.56
|
26.1 Percentage of days
Standard Error 5.86
|
19.1 Percentage of days
Standard Error 5.68
|
|
Percentage of Heartburn-Free 24-hour Days
Week 8
|
82.4 Percentage of days
Standard Error 6.59
|
73.8 Percentage of days
Standard Error 6.51
|
78.6 Percentage of days
Standard Error 6.19
|
72.2 Percentage of days
Standard Error 6.78
|
59.2 Percentage of days
Standard Error 6.48
|
SECONDARY outcome
Timeframe: Weeks 1 and 8Population: The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the "Number Analyzed" in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week.
Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms, or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. Heartburn assessed the severity as per the following scores (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, 5=Severe). Here higher scores represent the worst outcome, whereas lower scores represent the better outcome. After endoscopic evaluation, patients received lansoprazole, and symptom evaluation was conducted to detect patterns. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation involved the use of validated PRO QOLRAD (Heartburn version) and patient diaries.
Outcome measures
| Measure |
X842 25 mg BID
n=48 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=46 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=51 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=46 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=48 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Percentage at Most-mild Heartburn 24-hour Days
Week 1
|
75.3 Percentage of days
Standard Error 3.78
|
67.9 Percentage of days
Standard Error 3.85
|
79.4 Percentage of days
Standard Error 3.62
|
69.7 Percentage of days
Standard Error 3.81
|
63.1 Percentage of days
Standard Error 3.70
|
|
Percentage at Most-mild Heartburn 24-hour Days
Week 8
|
98.5 Percentage of days
Standard Error 4.34
|
96.5 Percentage of days
Standard Error 4.27
|
95.8 Percentage of days
Standard Error 4.08
|
97.1 Percentage of days
Standard Error 4.46
|
92.2 Percentage of days
Standard Error 4.26
|
SECONDARY outcome
Timeframe: Weeks 1 and 8Population: The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the "Number Analyzed" in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week.
Investigator assessed severity and frequency of patients' heartburn, regurgitation, and dysphagia in 7 days. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and frequency (for frequency, a 7-graded Likert scale was used, ranging from none to all of time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). Following endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD (Heartburn version) and patient diaries.Here, for frequency- All of the time and None of the time, and for symptoms- none and severe data has been presented.
Outcome measures
| Measure |
X842 25 mg BID
n=50 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=46 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=50 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=45 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=48 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Regurgitation/Reflux): Symptom- None
|
1 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Regurgitation/Reflux): Symptom- Severe
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Regurgitation/Reflux): Symptom- None
|
41 Participants
|
36 Participants
|
41 Participants
|
33 Participants
|
41 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Regurgitation/Reflux): Symptom- Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Dysphagia): Frequency- All of the time
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Dysphagia): Frequency- None of the time
|
14 Participants
|
10 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Dysphagia): Frequency- All of the time
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Dysphagia): Frequency- None of the time
|
42 Participants
|
37 Participants
|
43 Participants
|
34 Participants
|
40 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Heartburn): Frequency- All of the time
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Heartburn): Frequency- None of the time
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Heartburn): Frequency- All of the time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Heartburn): Frequency- None of the time
|
38 Participants
|
37 Participants
|
43 Participants
|
33 Participants
|
36 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Regurgitation/Reflux): Frequency- All of the time
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Regurgitation/Reflux): Frequency- None of the time
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Regurgitation/Reflux): Frequency- All of the time
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Regurgitation/Reflux): Frequency- None of the time
|
41 Participants
|
36 Participants
|
41 Participants
|
32 Participants
|
39 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Dysphagia): Symptom- None
|
14 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
12 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Dysphagia): Symptom- Severe
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Dysphagia): Symptom- None
|
42 Participants
|
37 Participants
|
43 Participants
|
35 Participants
|
41 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Dysphagia): Symptom- Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Heartburn): Symptom- None
|
1 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 1 (Heartburn): Symptom- Severe
|
5 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Heartburn): Symptom- None
|
38 Participants
|
37 Participants
|
44 Participants
|
33 Participants
|
38 Participants
|
|
Investigator Assessment of Symptoms by Frequency and Severity
Week 8 (Heartburn): Symptom- Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, and 8Population: The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. Here, the "Number Analyzed" in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week.
Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with 4 dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks of open-label treatment with Lansoprazole. Heartburn version of QOLRAD is a disease-specific instrument containing 25 questions addressing concerns associated with gastrointestinal symptoms. Questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as score increased, the patient's condition was considered better. Questions were categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning. The score in each domain was calculated as the mean of all items in that domain. The score ranges from 1 to 175, higher scores mean a better outcome. After endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD and patient diaries.
Outcome measures
| Measure |
X842 25 mg BID
n=40 Participants
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=40 Participants
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=41 Participants
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg+ X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=34 Participants
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=41 Participants
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 1: Sleep Disturbance Score
|
1.60 Scores on scale
Standard Error 0.250
|
1.45 Scores on scale
Standard Error 0.255
|
1.08 Scores on scale
Standard Error 0.236
|
1.49 Scores on scale
Standard Error 0.258
|
1.54 Scores on scale
Standard Error 0.244
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 8: Food/Drink Problems Score
|
3.08 Scores on scale
Standard Error 0.249
|
2.97 Scores on scale
Standard Error 0.259
|
2.34 Scores on scale
Standard Error 0.240
|
2.28 Scores on scale
Standard Error 0.264
|
2.56 Scores on scale
Standard Error 0.256
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 1: Physical/Social Functioning Score
|
1.26 Scores on scale
Standard Error 0.247
|
1.32 Scores on scale
Standard Error 0.252
|
1.02 Scores on scale
Standard Error 0.233
|
1.19 Scores on scale
Standard Error 0.255
|
0.97 Scores on scale
Standard Error 0.241
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 8: Physical/Social Functioning Score
|
2.06 Scores on scale
Standard Error 0.262
|
2.26 Scores on scale
Standard Error 0.271
|
1.57 Scores on scale
Standard Error 0.249
|
1.60 Scores on scale
Standard Error 0.274
|
1.71 Scores on scale
Standard Error 0.265
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 1: Emotional Distress Score
|
1.69 Scores on scale
Standard Error 0.247
|
1.55 Scores on scale
Standard Error 0.251
|
1.14 Scores on scale
Standard Error 0.233
|
1.54 Scores on scale
Standard Error 0.255
|
1.34 Scores on scale
Standard Error 0.241
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 8: Emotional Distress Score
|
2.76 Scores on scale
Standard Error 0.265
|
2.51 Scores on scale
Standard Error 0.275
|
1.84 Scores on scale
Standard Error 0.253
|
2.00 Scores on scale
Standard Error 0.278
|
2.19 Scores on scale
Standard Error 0.269
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 1: Food/Drink Problems Score
|
1.84 Scores on scale
Standard Error 0.229
|
1.62 Scores on scale
Standard Error 0.232
|
1.32 Scores on scale
Standard Error 0.217
|
1.65 Scores on scale
Standard Error 0.238
|
1.40 Scores on scale
Standard Error 0.223
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 1:Vitality Score
|
1.55 Scores on scale
Standard Error 0.237
|
1.51 Scores on scale
Standard Error 0.240
|
1.42 Scores on scale
Standard Error 0.224
|
1.50 Scores on scale
Standard Error 0.246
|
1.21 Scores on scale
Standard Error 0.231
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 8: Vitality Score
|
2.84 Scores on scale
Standard Error 0.257
|
2.79 Scores on scale
Standard Error 0.268
|
2.25 Scores on scale
Standard Error 0.247
|
2.21 Scores on scale
Standard Error 0.272
|
2.19 Scores on scale
Standard Error 0.264
|
|
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Week 8: Sleep Disturbance Score
|
2.78 Scores on scale
Standard Error 0.266
|
2.48 Scores on scale
Standard Error 0.276
|
1.89 Scores on scale
Standard Error 0.254
|
1.91 Scores on scale
Standard Error 0.279
|
2.37 Scores on scale
Standard Error 0.270
|
Adverse Events
X842 25 mg BID
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
X842 50 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
X842 75 mg BID
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
X842 100 mg BID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Lansoprazole
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
X842 25 mg BID
n=51 participants at risk
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=48 participants at risk
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=52 participants at risk
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=47 participants at risk
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=50 participants at risk
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
Other adverse events
| Measure |
X842 25 mg BID
n=51 participants at risk
Patients received 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 50 mg BID
n=48 participants at risk
Patients received 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 75 mg BID
n=52 participants at risk
Patients received 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
X842 100 mg BID
n=47 participants at risk
Patients received 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
Lansoprazole
n=50 participants at risk
Patients received 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients received 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Constipation
|
3.9%
2/51 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
3.8%
2/52 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
8.0%
4/50 • Number of events 4 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
4.2%
2/48 • Number of events 3 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
4.3%
2/47 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
2/51 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
4.3%
2/47 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
General disorders
Chest pain
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
General disorders
Fatigue
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
General disorders
Mucosal dryness
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
General disorders
Peripheral swelling
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
General disorders
Hepatobiliary disorders
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
COVID-19
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
4.2%
2/48 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
8.5%
4/47 • Number of events 4 • From Screening (Day -7 to Day 0) until Week 8
|
4.0%
2/50 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
4.2%
2/48 • Number of events 2 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Laryngitis
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Rhinitis
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
6.2%
3/48 • Number of events 3 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/47 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 9 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
2.1%
1/48 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
1.9%
1/52 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/51 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/50 • From Screening (Day -7 to Day 0) until Week 8
|
|
Vascular disorders
Hypertension
|
0.00%
0/51 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/48 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/52 • From Screening (Day -7 to Day 0) until Week 8
|
0.00%
0/47 • From Screening (Day -7 to Day 0) until Week 8
|
2.0%
1/50 • Number of events 1 • From Screening (Day -7 to Day 0) until Week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains confidential information about Cinclus Pharma Holding AB. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor use it for unauthorized purposes. In the event of an actual or suspected breach of this obligation, Cinclus Pharma Holding AB should be promptly notified.
- Publication restrictions are in place
Restriction type: OTHER