Trial Outcomes & Findings for A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee (NCT NCT02944448)
NCT ID: NCT02944448
Last Updated: 2020-10-20
Results Overview
11-point NRS scale where 0 = no pain, and 10= pain as bad as you can imagine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
761 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
CR845 Tablet
Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
Twice daily dosing (BID)
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
160
|
|
Overall Study
COMPLETED
|
227
|
136
|
|
Overall Study
NOT COMPLETED
|
89
|
24
|
Reasons for withdrawal
| Measure |
CR845 Tablet
Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
Twice daily dosing (BID)
|
|---|---|---|
|
Overall Study
Adverse Event
|
37
|
6
|
|
Overall Study
Lack of Efficacy
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
25
|
7
|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
|
Overall Study
Sponsor did not supply drug in time
|
0
|
1
|
|
Overall Study
Noncompliant with dosing
|
1
|
0
|
|
Overall Study
Abnormal laboratory values
|
1
|
0
|
Baseline Characteristics
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
Baseline characteristics by cohort
| Measure |
CR845 Tablet
n=316 Participants
Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
Total
n=476 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.26 • n=93 Participants
|
60.8 years
STANDARD_DEVIATION 10.26 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 10.25 • n=27 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
299 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
177 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
245 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
367 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 811-point NRS scale where 0 = no pain, and 10= pain as bad as you can imagine
Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Change From Baseline at Week 8 With Respect to the Weekly Mean of the Daily 24-hour Pain Intensity for the Index Joint as Measured by the Numeric Rating Scale (NRS).
|
-2.3 score on a scale
Standard Error 0.14
|
-2.4 score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 8The WOMAC Index is a self-administered assessment used to measure pain, stiffness, and physical function in patients with osteoarthritis. The WOMAC Index contains 24 questions across 3 different sub-scales (pain, stiffness, and function) all with scoring 0-10 (0 = No Pain/Stiffness/Difficulty, 10 = Extreme Pain/Stiffness/Difficulty). Each WOMAC Index Subscale score (Pain/Stiffness/Function) is calculated as the sum of all scores within that subscale. The pain subscale consists of five scores from 0-10, 0 is no pain 10 is extreme pain possible for a range of 0 - 50 points. The stiffness subscale consists of two scores from 0-10, 0 is no stiffness 10 is extreme stiffness possible for a range of 0 - 20 points. The function subscale consists of 17 scores from 0-10, 0 is no difficulty and 10 is extreme difficulty, for a range of 0 - 170 points. The WOMAC Index Total Score is calculated as the sum of all 24 scores (range of 0-240).
Outcome measures
| Measure |
CR845 Tablet
n=223 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=133 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Change From Baseline in the Western Ontario & McMaster Osteoarthritis (WOMAC) Index Total Score at Week 8
|
-62.4 score on a scale
Standard Error 3.28
|
-59.7 score on a scale
Standard Error 4.34
|
SECONDARY outcome
Timeframe: Baseline, Week 8The pain subscale consists of five scores from 0-10, 0 is no pain 10 is extreme pain possible for a range of 0 - 50 points.
Outcome measures
| Measure |
CR845 Tablet
n=223 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=133 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Change From Baseline in the WOMAC Pain Intensity Sub-scale Score at Week 8
|
-13.5 score on a scale
Standard Error 0.70
|
-12.7 score on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline, Week 8The stiffness subscale consists of two scores from 0-10, 0 is no stiffness 10 is extreme stiffness possible for a range of 0 - 20 points.
Outcome measures
| Measure |
CR845 Tablet
n=223 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=133 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Change From Baseline in the WOMAC Stiffness Sub-scale Score at Week 8
|
-5.7 score on a scale
Standard Error 0.29
|
-5.6 score on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 8The function subscale consists of 17 scores from 0-10, 0 is no difficulty and 10 is extreme difficulty, for a range of 0 - 170 points.
Outcome measures
| Measure |
CR845 Tablet
n=223 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=133 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Change From Baseline in the WOMAC Function Sub-scale Score at Week 8
|
-43.1 score on a scale
Standard Error 2.34
|
-41.5 score on a scale
Standard Error 3.10
|
SECONDARY outcome
Timeframe: Week 8A patient's pain response to treatment is defined as the percent improvement from baseline with respect to the weekly mean of "average pain in the last 24 hours" pain score during the last week of the Maintenance Treatment Period (Week 8) . If a patient's mean weekly pain score during the last week of the Maintenance Treatment Period is greater than the baseline score (i.e., the patient has an increase in pain compared to baseline), his/her response to treatment will be assigned a value of 0 (i.e. the patient will be considered a non-responder). Patients who discontinue study drug early will be considered non-responders to treatment and will be assigned a pain response of 0. The percentage of subjects achieving levels of treatment response 10% to 100% by 10% increments as defined above will be calculated with 30% of key interest as it has been shown to represent a clinically important improvement in pain.
Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Proportion of Patients With at Least 30% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8
|
41.5 percentage of patients
|
50.6 percentage of patients
|
SECONDARY outcome
Timeframe: Week 8A patient's pain response to treatment is defined as the percent improvement from baseline with respect to the weekly mean of "average pain in the last 24 hours" pain score during the last week of the Maintenance Treatment Period (Week 8) . If a patient's mean weekly pain score during the last week of the Maintenance Treatment Period is greater than the baseline score (i.e., the patient has an increase in pain compared to baseline), his/her response to treatment will be assigned a value of 0 (i.e. the patient will be considered a non-responder). Patients who discontinue study drug early will be considered non-responders to treatment and will be assigned a pain response of 0. The percentage of subjects achieving levels of treatment response 10% to 100% by 10% increments as defined above will be calculated with 30% of key interest as it has been shown to represent a clinically important improvement in pain.
Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Proportion of Patients With at Least 50% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8
|
25.6 percentage of patients
|
31.3 percentage of patients
|
SECONDARY outcome
Timeframe: Week 8The PGIC is a self-administered instrument that measures the patient's overall impression of his/her OA on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse".
Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Proportion of Patients Whose OA Pain Was "Very Much Improved" or "Much Improved" as Indicated by Patient Global Impression of Change (PGIC) Score at Week 8
|
44.3 percentage of patients
|
40.0 percentage of patients
|
SECONDARY outcome
Timeframe: Week 8The average daily number of acetaminophen tablets used during the study will be calculated using data recorded in the patient diary as the sum of the total number of tablets used divided by the length of exposure (in days). The supplemental pain medication for OA will be grouped categorically into the following classes: (1) no supplemental acetaminophen tablets, (2) 0 to ≤ 0.5 tablets, (3) \> 0.5 to ≤ 1.0 tablets, (4) \> 1.0 to ≤ 2.0 tablets, and (5) \> 2.0 tablets.
Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Average Daily Number of Acetaminophen Tablets Used During Entire Study
|
0.5 Tablets
Standard Deviation 2.27
|
0.4 Tablets
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Week 8Outcome measures
| Measure |
CR845 Tablet
n=316 Participants
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 Participants
Twice daily dosing (BID)
|
|---|---|---|
|
Proportion of Patients Withdrawing From Treatment Due to Lack of Analgesic Efficacy
|
2.5 percentage of patients
|
3.1 percentage of patients
|
Adverse Events
CR845 Tablet
Serious events: 9 serious events
Other events: 82 other events
Deaths: 0 deaths
Placebo Tablet
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CR845 Tablet
n=316 participants at risk
Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 participants at risk
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
Placebo tablet: Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.62%
1/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.62%
1/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Psychiatric disorders
Mental Status Changes
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.32%
1/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
0.00%
0/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
Other adverse events
| Measure |
CR845 Tablet
n=316 participants at risk
Every patient was started on a twice daily (BID) 1 mg dose of CR845. During the post-randomization Titration-to-Effect Period, the dose of study drug may have been increased to 2.5 mg BID or 5 mg BID in a double-blind fashion.
|
Placebo Tablet
n=160 participants at risk
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
Placebo tablet: Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.3%
42/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
1.9%
3/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Nervous system disorders
Dizziness
|
8.2%
26/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
1.9%
3/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Nervous system disorders
Headache
|
5.7%
18/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
5.6%
9/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
18/316 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
1.9%
3/160 • 59 Days
Treatment emergent AEs (TEAEs) will be defined as AEs where onset occurs from the day of first dose of study medication up to and including the 2nd day following the day of last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place