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| Name | Class |
|---|---|
| Merck S.A. de C.V., Mexico | INDUSTRY |
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This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.
Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.
OBJECTIVES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F0434 | Experimental |
| |
| Gabapentin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F0434 | Drug | F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Neuropathic Pain Score at Visit 3 (Week 1) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | Visit 3 (Week 1) |
| Mean Neuropathic Pain Score at Visit 4 (Week 2) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | Visit 4 (Week 2) |
| Mean Neuropathic Pain Score at Visit 5 (Week 3) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | Visit 5 (Week 3) |
| Mean Neuropathic Pain Score at Visit 6 (Week 4) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | Visit 6 (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck S.A. de C.V., Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REMEDI Resultados Médicos Desarrollo e Investigación, S.C. | Pachuca | Hidalgo | 42090 | Mexico |
A total of 104 participants were recruited for the study, out of which 29 participants were screen failures which were not randomized and did not receive study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule. |
| FG001 | MF0434 + Gabapentin | MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule. |
| BG001 | MF0434 + Gabapentin |
| 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 | Mean Neuropathic Pain Score at Visit 3 (Week 1) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 3 (Week 1) |
|
Up to 4 weeks
An adverse event (AE) was 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.
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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 | Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Responsible | Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D011115 | Polyneuropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D013831 | Thiamine |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Gabapentin | Drug | Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2) |
|
|
| Visit 2 (Baseline) to Visit 6 (Week 4) |
MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MF0434 + Gabapentin | MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule. |
|
|
| Secondary | Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status. | PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 2 (Baseline) to Visit 6 (Week 4) |
|
|
|
| Primary | Mean Neuropathic Pain Score at Visit 4 (Week 2) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 4 (Week 2) |
|
|
|
| Primary | Mean Neuropathic Pain Score at Visit 5 (Week 3) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 5 (Week 3) |
|
|
|
| Primary | Mean Neuropathic Pain Score at Visit 6 (Week 4) | Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. | PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 6 (Week 4) |
|
|
|
| 0 |
| 38 |
| 22 |
| 38 |
| EG001 | MF0434 + Gabapentin | MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule. | 0 | 37 | 23 | 37 |
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Lower Limb Edema | General disorders | Non-systematic Assessment |
|
| Viral Rhinopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute Otitis Media | Infections and infestations | Non-systematic Assessment |
|
| Edema | General disorders | Non-systematic Assessment |
|
| Widespread Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Pyrosis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Week 2 (Visit 4): General SF-36 QoL Index |
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| Week 3 (Visit 5): General SF-36 QoL Index |
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| Week 4 (Visit 6): General SF-36 QoL Index |
|