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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study is being conducted to evaluate the hypothesis that use of Treximet in patients with chronic migraine, when used on a short term daily basis and as rescue for break through attacks, will reduce migraine frequency and impact.
One investigative center will enroll 40 subjects in the US.
At Visit 1, following informed consent, a medical, migraine, and medication history will be collected and a physical and neurological exam with vital signs will be performed. A 12-lead ECG will be completed. Eligible subjects will complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice. Throughout the study, subjects will complete daily Headache Diaries reporting headache severity and associated symptoms with use of study medication in each 30-day period.
At Visit 2, subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with medication to treat daily for 30 days. At Visits 3 and 4 subjects will be provided with study medication to treat on 14 or fewer days per month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of headache pain and while the pain is still mild. Adverse events will be collected beginning from the first dose of study medication. Subjects exit the study at Visit 5 after a 3-month Treatment Period.
The study provides opportunity to evaluate the usefulness of patient education with a 15-minute digital versatile disc (DVD) concerning the processes of headache evolution and lifestyle changes for better headache management. At Visit 2, subjects will view the DVD in-clinic with a copy provided for at-home viewing. Subjects will complete a Lifestyle Choices for Better Migraine Management Questionnaire at each visit and receive 3 copies to be completed weekly and returned at the following visit.
The Migraine Disability Assessment questionnaire (MIDAS) will be completed at Visits 2 and 5 to determine the level of pain and disability caused by headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sumatriptan/Naproxen Sodium | Active Comparator | In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan 85mg / Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. |
|
| Naproxen Sodium | Active Comparator | In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan/Naproxen Sodium | Drug | Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Migraine Headache Days Compared to Baseline | Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%) | Day 121 (following 30 day Baseline Period and Treatment Period days 91-120. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline | Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%) |
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Inclusion Criteria:
Subject
Exclusion Criteria:
Subject
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| Name | Affiliation | Role |
|---|---|---|
| Roger K Cady, MD | Clinvest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinvest | Springfield | Missouri | 65807 | United States | ||
| Texas Headache Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24020994 | Derived | Cady R, Nett R, Dexter K, Freitag F, Beach ME, Manley HR. Treatment of chronic migraine: a 3-month comparator study of naproxen sodium vs SumaRT/Nap. Headache. 2014 Jan;54(1):80-93. doi: 10.1111/head.12210. Epub 2013 Sep 10. |
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Subjects completed a 30 day Baseline period between Visit 1 and Visit 2 before Randomization. Subjects must have had 15 or more headache days during the 30 day Baseline period in order to be randomized into the study Treatment periods. Fifty-six subjects were screened for study, however only 28 subjects randomized for treatment due to screen fail.
Recruitment period was from date of Institutional Review Board (IRB) approval (8-3-10) until date last patient enrolled (1-30-12). Subjects were recruited from general population at two clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sumatriptan/Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. |
| FG001 | Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sumatriptan/Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change of Migraine Headache Days Compared to Baseline | Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%) | Posted | Mean | Standard Deviation | percent migraine headache days per month | Day 121 (following 30 day Baseline Period and Treatment Period days 91-120. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sumatriptan/Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanne Tarrasch | Clinvest/A Division of Banyan Group Inc. | 417-841-3673 | jtarrasch@clinvest.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| C000611385 | sumatriptan-naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
|
| Naproxen Sodium | Drug | Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3. |
|
| Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively. |
| Migraine Headache Duration From Onset to Pain Free | Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%) | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. |
| Migraine Headache Duration From Time of Treatment to Pain Free | Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%) | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. |
| Migraine Headache Days With Greater Than 50% Reduction | Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. |
| Percent Change of Doses of Study Medication | Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%). | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. |
| Migraine Disability Assessment(MIDAS)Questionnaire Total Score | Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm. Total score of disability ranges:
| Baseline MIDAS collected at Day 31, Post final dose study at Day 121. |
| Compliance With Lifestyle Changes | Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome. | Day 121 |
| San Antonio |
| Texas |
| 78258 |
| United States |
| Physician Decision |
|
| BG001 | Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue. |
|
|
| Secondary | Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline | Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%) | Posted | Mean | Standard Deviation | percent migraine headache days per month | Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively. |
|
|
|
| Secondary | Migraine Headache Duration From Onset to Pain Free | Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%) | Posted | Mean | Standard Deviation | percent hours of migraine duration | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. |
|
|
|
| Secondary | Migraine Headache Duration From Time of Treatment to Pain Free | Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%) | Posted | Mean | Standard Deviation | percent hours of migraine duration | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively. |
|
|
|
| Secondary | Migraine Headache Days With Greater Than 50% Reduction | Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. | Posted | Number | participants | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. |
|
|
|
| Secondary | Percent Change of Doses of Study Medication | Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%). | Posted | Mean | Standard Deviation | percent doses of study medication | Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively. |
|
|
|
| Secondary | Migraine Disability Assessment(MIDAS)Questionnaire Total Score | Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm. Total score of disability ranges:
| Posted | Mean | Standard Deviation | scores on a scale | Baseline MIDAS collected at Day 31, Post final dose study at Day 121. |
|
|
|
| Secondary | Compliance With Lifestyle Changes | Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome. | Posted | Mean | Standard Deviation | Units on a scale | Day 121 |
|
|
|
| 1 |
| 16 |
| 9 |
| 16 |
| EG001 | Naproxen Sodium | In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue. | 1 | 12 | 6 | 12 |
| Menorragia | Reproductive system and breast disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Enhanced Smell | General disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Flu | Infections and infestations | Systematic Assessment |
|
| Fluid in Ears | Ear and labyrinth disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea with Fatty Foods | Gastrointestinal disorders | Systematic Assessment |
|
| Numb Feeling in Head | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain Behind Eyes | General disorders | Systematic Assessment |
|
| Right Ankle Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right Leg Ulcer | Infections and infestations | Systematic Assessment |
|
| Sinus Burning Sensation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus Discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Stomach Burn | Gastrointestinal disorders | Systematic Assessment |
|
| Strep Throat | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Worsening Stress | Psychiatric disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Baseline to Treatment Period Month 3 |
|
| Baseline to Treatment Period Month 3 |
|
| Baseline to Treatment Period Month 3 |
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| Baseline to Treatment Period Month 3 |
|
| Baseline to Treatment Period Month 3 |
|