Trial Outcomes & Findings for Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen. (NCT NCT04611529)
NCT ID: NCT04611529
Last Updated: 2024-10-09
Results Overview
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
COMPLETED
PHASE4
198 participants
Baseline to 48 hours
2024-10-09
Participant Flow
Enrollment commenced in March 2021 and concluded in June 2023. The study was conducted in 2 Emergency Departments (EDs) both affiliated with Montefiore Medical Center.
In total, 3281 patients were screened for participation and 198 were randomized into the study. 1 patient was excluded post-randomization due to missing RMDQ data.
Participant milestones
| Measure |
Oral Ibuprofen + Topical Diclofenac
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
2-day Follow up
STARTED
|
65
|
66
|
66
|
|
2-day Follow up
COMPLETED
|
60
|
60
|
63
|
|
2-day Follow up
NOT COMPLETED
|
5
|
6
|
3
|
|
7-day Follow up
STARTED
|
60
|
60
|
63
|
|
7-day Follow up
COMPLETED
|
60
|
60
|
63
|
|
7-day Follow up
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Oral Ibuprofen + Topical Diclofenac
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
2-day Follow up
Lost to Follow-up
|
5
|
6
|
3
|
Baseline Characteristics
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Baseline characteristics by cohort
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=65 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=66 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=66 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13 • n=5 Participants
|
37 years
STANDARD_DEVIATION 13 • n=7 Participants
|
39 years
STANDARD_DEVIATION 13 • n=5 Participants
|
38 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
51 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Refused
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
66 participants
n=7 Participants
|
66 participants
n=5 Participants
|
197 participants
n=4 Participants
|
|
Roland-Morris Disability Questionnaire (RMDQ) at ED visit
|
19 score on a scale
n=5 Participants
|
19 score on a scale
n=7 Participants
|
17 score on a scale
n=5 Participants
|
18 score on a scale
n=4 Participants
|
|
Duration of Low Back Pain before presentation to ED
|
72 hours
n=5 Participants
|
48 hours
n=7 Participants
|
48 hours
n=5 Participants
|
56 hours
n=4 Participants
|
|
Patients with Previous Episodes of Low Back Pain
Never Before
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Patients with Previous Episodes of Low Back Pain
Few Times Before
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Patients with Previous Episodes of Low Back Pain
Once a Year
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Patients with Previous Episodes of Low Back Pain
Once a Month
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 48 hoursPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up (LTFU) prior to the 48 hour assessment timepoints.
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=60 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=63 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
|
8.7 score on a scale
Interval 6.3 to 11.1
|
10.1 score on a scale
Interval 7.5 to 12.7
|
6.4 score on a scale
Interval 4.0 to 8.8
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group.
Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=63 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=63 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Worst Low Back Pain (LBP)
None
|
5 Participants
|
11 Participants
|
8 Participants
|
|
Worst Low Back Pain (LBP)
Mild
|
27 Participants
|
28 Participants
|
21 Participants
|
|
Worst Low Back Pain (LBP)
Moderate
|
18 Participants
|
14 Participants
|
23 Participants
|
|
Worst Low Back Pain (LBP)
Severe
|
13 Participants
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were LTFU prior to 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group.
Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=63 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=62 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Use of Medication for Low Back Pain (LBP)
Yes
|
54 Participants
|
53 Participants
|
50 Participants
|
|
Use of Medication for Low Back Pain (LBP)
No
|
9 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data regarding Frequency of Low Back Pain was not collected.
Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data related to the percentage of patients who were able to return to usual activities was not collected.
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data related to the number of visits to any healthcare provider was not collected.
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data related to treatment satisfaction was not collected.
Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up prior to the 7-day assessment timepoints.
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability).
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=60 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=63 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
|
10.7 score on a scale
Interval 8.4 to 13.0
|
12.2 score on a scale
Interval 9.8 to 14.6
|
9.5 score on a scale
Interval 7.1 to 12.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group.
Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=61 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=62 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Worst Low Back Pain (LBP)
None
|
20 Participants
|
24 Participants
|
15 Participants
|
|
Worst Low Back Pain (LBP)
Mild
|
21 Participants
|
23 Participants
|
24 Participants
|
|
Worst Low Back Pain (LBP)
Moderate
|
13 Participants
|
9 Participants
|
16 Participants
|
|
Worst Low Back Pain (LBP)
Severe
|
7 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group.
Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.
Outcome measures
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=61 Participants
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 Participants
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=63 Participants
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Use of Medication for Low Back Pain (LBP)
Yes
|
33 Participants
|
31 Participants
|
35 Participants
|
|
Use of Medication for Low Back Pain (LBP)
No
|
28 Participants
|
29 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Data regarding Frequency of Low Back Pain was not collected.
Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Data related to the percentage of patients who were able to return to usual activities was not collected.
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Data related to the number of visits to any healthcare provider was not collected.
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Data related to treatment satisfaction was not collected.
Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Outcome measures
Outcome data not reported
Adverse Events
Oral Ibuprofen + Topical Diclofenac
Oral Ibuprofen + Topical Placebo
Oral Placebo + Topical Diclofenac
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Ibuprofen + Topical Diclofenac
n=60 participants at risk
Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm
|
Oral Ibuprofen + Topical Placebo
n=60 participants at risk
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
|
Oral Placebo + Topical Diclofenac
n=63 participants at risk
Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm
|
|---|---|---|---|
|
Nervous system disorders
Drowsiness
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
3.3%
2/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
1.6%
1/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
General disorders
Chills
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/60 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
0.00%
0/63 • From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place