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| Name | Class |
|---|---|
| Merck S.A. de C.V., Mexico | INDUSTRY |
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This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral neuropathy pain (DPNP) management.
Primary Objective:
To compare the efficacy of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate diabetic peripheral neuropathy (DPN) of acute or chronic presentation.
Secondary Objectives:
To determine the safety and tolerability of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate DPN of acute or chronic presentation.
Subjects will be randomized in a 1:1 ratio to receive gabapentin/B-complex or pregabalin.
The duration of treatment per subject will be 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin/B-complex | Experimental |
| |
| Pregabalin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin/B-complex | Drug | Gabapentin/B-complex (Gavindo®) tablet will be administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed will be 3600 mg/day. The total duration of treatment will be 84 days (12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84 | An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84. | Baseline and Day 84 (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84 | The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The first 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their significance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Research Manager | Merck S.A de C.V, Mexiko, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26885528 | Derived | Mimenza Alvarado A, Aguilar Navarro S. Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy. J Diabetes Res. 2016;2016:4078695. doi: 10.1155/2016/4078695. Epub 2016 Jan 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin/B-complex | Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| FG001 | Pregabalin | Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all the randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin/B-complex | Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84 | An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84. | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 (Week 12) |
|
Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
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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 | Gabapentin/B-complex | Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular disorder | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
|
| Pregabalin | Drug | Pregabalin (Lyrica®) capsule will be administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed will be 600 mg/day. The total duration of treatment will be 84 days (12 weeks). |
|
|
| Baseline and Day 84 (Week 12) |
| Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84 | VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84. | Baseline and Day 84 (Week 12) |
| Profile of Mood States (POMS) Score | POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means "not at all" and 4 "extremely". The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score. | Day 84 (Week 12) |
| Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration | Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12). | Day 84 (Week 12) |
| Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale | GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). | Baseline and Day 84 (Week 12) |
| Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale | CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). | Baseline and Day 84 (Week 12) |
| Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12) | NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. | Baseline and Day 84 (Week 12) |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. | Day 7 up to Day 84 (+7 days) |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| BG001 | Pregabalin | Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks). |
| OG001 | Pregabalin | Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks). |
|
|
| Secondary | Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84 | The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The first 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their significance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84. | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 (Week 12) |
|
|
|
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84 | VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84. | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Posted | Mean | Standard Deviation | centimeter | Baseline and Day 84 (Week 12) |
|
|
|
| Secondary | Profile of Mood States (POMS) Score | POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means "not at all" and 4 "extremely". The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score. | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. | Posted | Mean | Standard Deviation | units on a scale | Day 84 (Week 12) |
|
|
|
| Secondary | Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration | Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12). | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. | Posted | Number | participants | Day 84 (Week 12) |
|
|
|
| Secondary | Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale | GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Number | participants | Baseline and Day 84 (Week 12) |
|
|
|
| Secondary | Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale | CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Number | participants | Baseline and Day 84 (Week 12) |
|
|
|
| Secondary | Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12) | NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. | Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. | Posted | Number | percentage of participants | Baseline and Day 84 (Week 12) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. | Safety population included all the randomized participants who received at least one dose of study drug. | Posted | Number | participants | Day 7 up to Day 84 (+7 days) |
|
|
|
| 1 |
| 174 |
| 79 |
| 174 |
| EG001 | Pregabalin | Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks). | 0 | 174 | 93 | 174 |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Vascular insufficiency | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Oedema | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 31 to 45 minutes |
|
| 46 to 60 minutes |
|
| Greater than 60 minutes |
|
| Health: minimally improved |
|
| Health: minimally improved |
|