Trial Outcomes & Findings for Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD) (NCT NCT02966873)
NCT ID: NCT02966873
Last Updated: 2025-02-06
Results Overview
Change in Alcohol Use Severity as measured by standard drinks per day using the Time Line Follow Back (TLFB) to measure alcohol consumption. Fewer standard drinks per day represent better outcomes. Greater change in standard drinks per day represents better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
182 participants
Primary outcome timeframe
From baseline to week 12
Results posted on
2025-02-06
Participant Flow
Recruitment for this project was ongoing from June 2016 through June 2021. Prior to the Coronavirus pandemic, recruitment efforts were focused in Charleston, South Carolina (clinics, online, community). In 2020, the study team shifted to a full remote approach and opened recruitment across the continental United States.
Participants were stratified by alcohol use disorder severity and posttraumatic stress disorder severity. Stratified random block randomization was used to balance the randomization assignment with respect to these strata. The purpose of stratification is to distribute these potential prognostic factors equally across treatment groups.
Participant milestones
| Measure |
N-Acetylcysteine (NAC) Treatment Group
Participant will receive 12 weeks of Active Treatment N-Acetylcysteine (NAC) (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
89
|
|
Overall Study
COMPLETED
|
77
|
74
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
N-Acetylcysteine (NAC) Treatment Group
Participant will receive 12 weeks of Active Treatment N-Acetylcysteine (NAC) (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
15
|
Baseline Characteristics
Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=93 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=89 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, % Hispanic
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Alcohol Use Severity as measured by standard drinks per day using the Time Line Follow Back (TLFB) to measure alcohol consumption. Fewer standard drinks per day represent better outcomes. Greater change in standard drinks per day represents better outcomes.
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=75 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=73 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Alcohol Use Severity
|
-3.406 standard drinks per day
Standard Deviation 3.738
|
-3.934 standard drinks per day
Standard Deviation .825
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the obsessive subscale of alcohol craving. The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Obsessive subscale includes items 1-6. Each item is scored on a scale from 0 to 4. Scores range from 0 to 28, with lower scores representing better outcomes.
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=77 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=73 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Alcohol Craving - Obsessive Subscale
|
-2.597 units on a scale
Standard Deviation 4.314
|
-2.521 units on a scale
Standard Deviation 3.738
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Post Traumatic Stress Disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=74 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=73 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
|
-11.838 units on a scale
Standard Deviation 9.834
|
-13.863 units on a scale
Standard Deviation 10.87
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Post Traumatic Stress Disorder (PTSD) symptom severity as measured by the Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\](PCL-5) for self-reported symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=78 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=74 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report
|
-15.997 units on a scale
Standard Deviation 18.907
|
-18.129 units on a scale
Standard Deviation 18.37
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the compulsive subscale of alcohol craving. The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Compulsive subscale includes items 7-14. Each item is scored on a scale from 0 to 4. Scores range from 0 to 32, with lower scores representing better outcomes.
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=77 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=74 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Alcohol Craving - Compulsive Subscale
|
-4.584 units on a scale
Standard Deviation 3.971
|
-4.905 units on a scale
Standard Deviation 4.266
|
PRIMARY outcome
Timeframe: From baseline to week 12Change in Alcohol Use Severity as measured by the percent days abstinent using the Time Line Follow Back (TLFB) to measure alcohol consumption. Greater percentage of days of abstinence represents better outcomes. Greater change in Percent Days Abstinent represents better outcomes.
Outcome measures
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=75 Participants
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=73 Participants
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Change in Alcohol Use Severity - Percent Days Abstinent
|
35.6 percentage of days abstinent for alcohol
Standard Deviation 35.2
|
31.7 percentage of days abstinent for alcohol
Standard Deviation 34.9
|
Adverse Events
N-Acetylcysteine (NAC) Treatment Group
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo Group
Serious events: 3 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=93 participants at risk
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=89 participants at risk
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury/Accident
|
1.1%
1/93 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
1.1%
1/89 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Reproductive system and breast disorders
Ectopic Pregnancy & Ruptured Fallopian Tube
|
0.00%
0/93 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
1.1%
1/89 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/93 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
1.1%
1/89 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.2%
2/93 • Number of events 2 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
0.00%
0/89 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Nervous system disorders
Stroke
|
1.1%
1/93 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
0.00%
0/89 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Infections and infestations
Sepsis
|
1.1%
1/93 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
0.00%
0/89 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Renal and urinary disorders
Pancreatitis
|
1.1%
1/93 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
0.00%
0/89 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Renal and urinary disorders
Bladder Infection
|
1.1%
1/93 • Number of events 1 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
0.00%
0/89 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
Other adverse events
| Measure |
N-Acetylcysteine (NAC) Treatment Group
n=93 participants at risk
Participant will receive 12 weeks of Active Treatment NAC (2400 milligrams \[mg\]) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
Placebo Group
n=89 participants at risk
Participants receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
The study medication (placebo) provided in blister packs in the form of 600 milligrams \[mg\] tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Cognitive Behavioral Therapy (CBT): All participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
2.2%
2/93 • Number of events 4 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
7.9%
7/89 • Number of events 11 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/93 • Number of events 2 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
4.5%
4/89 • Number of events 5 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
22.6%
21/93 • Number of events 23 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
10.1%
9/89 • Number of events 11 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Nervous system disorders
Headache/Migraine
|
4.3%
4/93 • Number of events 4 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
14.6%
13/89 • Number of events 14 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Injury, poisoning and procedural complications
Injury
|
9.7%
9/93 • Number of events 12 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
9.0%
8/89 • Number of events 9 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Musculoskeletal and connective tissue disorders
Muscle or Joint Pain
|
7.5%
7/93 • Number of events 9 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
11.2%
10/89 • Number of events 16 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Gastrointestinal disorders
Nausea
|
9.7%
9/93 • Number of events 9 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
5.6%
5/89 • Number of events 6 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Infections and infestations
Sinusitis
|
3.2%
3/93 • Number of events 3 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
6.7%
6/89 • Number of events 9 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Infections and infestations
Viral Upper Respiratory Tract Infections (Cold)
|
16.1%
15/93 • Number of events 17 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
15.7%
14/89 • Number of events 17 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
5/93 • Number of events 5 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
2.2%
2/89 • Number of events 2 • Approximately 1 year and 3 months (from start of baseline appointment through 12 week treatment phase and 1 year follow up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place