A Phase 3 interventional study of F0434 and Gabapentin in Diabetic Neuropathies and Polyneuropathies, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-02-13.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 3, Interventional, and Treatment
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
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 104 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
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Drug: F0434
Drug: Gabapentin
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).
Also known as: Gabapentin with thiamine and cobalamin
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)
Also known as: Gababion, Gavindo
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 6 (Week 4)
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.
Time frame: Visit 2 (Baseline) to Visit 6 (Week 4)
| Milestone | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Started | 38 | 37 |
| Completed | 38 | 37 |
| Not completed | 0 | 0 |
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.
| Units on a Scale | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Mean Neuropathic Pain Score at Visit 3 (Week 1) | 51.00 ± 17.39 | 50.70 ± 16.67 |
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.
| Units on a Scale | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Baseline (Visit 2): General SF-36 QoL Index | 53.044 ± 22.409 | 56.507 ± 19.523 |
| Week 1 (Visit 3): General SF-36 QoL Index | 65.779 ± 20.882 | 65.610 ± 18.599 |
| Week 2 (Visit 4): General SF-36 QoL Index | 69.531 ± 18.987 | 74.370 ± 15.595 |
| Week 3 (Visit 5): General SF-36 QoL Index | 73.058 ± 18.102 | 78.075 ± 15.819 |
| Week 4 (Visit 6): General SF-36 QoL Index | 78.869 ± 17.010 | 82.331 ± 15.793 |
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.
| Units on a Scale | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Mean Neuropathic Pain Score at Visit 4 (Week 2) | 41.24 ± 16.21 | 36.94 ± 15.05 |
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.
| Units on a Scale | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Mean Neuropathic Pain Score at Visit 5 (Week 3) | 33.74 ± 19.54 | 24.86 ± 13.52 |
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.
| Units on a Scale | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| Mean Neuropathic Pain Score at Visit 6 (Week 4) | 22.08 ± 18.54 | 17.29 ± 15.53 |
Collected over Up to 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | — | 0/38 (0%) | 22/38 (57.9%) |
| MF0434 + Gabapentin | — | 0/37 (0%) | 23/37 (62.2%) |
| Event | Gabapentin | MF0434 + Gabapentin |
|---|---|---|
| DizzinessNervous system disorders | 12/38 | 20/37 |
| DrowsinessNervous system disorders | 13/38 | 6/37 |
| HeadacheNervous system disorders | 3/38 | 4/37 |
| Lower Limb EdemaGeneral disorders | 1/38 | 2/37 |
| HypoglycemiaMetabolism and nutrition disorders | 2/38 | 1/37 |
| Acute Otitis MediaInfections and infestations | 0/38 | 1/37 |
| EdemaGeneral disorders | 0/38 | 1/37 |
| Widespread UrticariaSkin and subcutaneous tissue disorders | 0/38 | 1/37 |
| HypertensionVascular disorders | 0/38 | 1/37 |
| PyrosisGastrointestinal disorders | 0/38 | 1/37 |
| Age, Continuous(years) | Gabapentin | MF0434 + Gabapentin | Total |
|---|---|---|---|
| Mean | 52.6 ± 9.7 | 51.1 ± 9.9 | 51.9 ± 9.8 |
| Sex: Female, Male(Participants) | Gabapentin | MF0434 + Gabapentin | Total |
|---|---|---|---|
| Female | 19 | 21 | 40 |
| Male | 19 | 16 | 35 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany