Trial · NCT01263132
Neuropathic Pain Management
NCT01263132, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2011-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neuropathic Pain Management. Trials, record NCT01263132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263132
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neuropathic Pain Management
- NCT number
- NCT01263132
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Diabetic Neuropathies, Polyneuropathies
- Interventions
- F0434, Gabapentin
- First posted
- 2010-12-20
- Last updated
- 2014-02-13
- Results first posted
- 2011-10-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Neuropathic Pain Score at Visit 3 (Week 1) | 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. |
| Primary | Mean Neuropathic Pain Score at Visit 4 (Week 2) | 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. |
| Primary | Mean Neuropathic Pain Score at Visit 5 (Week 3) | 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. |
| Primary | Mean Neuropathic Pain Score at Visit 6 (Week 4) | 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. |
| Secondary | Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Visit 2 (Baseline) to Visit 6 (Week 4) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Neuropathic Pain Score at Visit 3 (Week 1) | Visit 3 (Week 1) | 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. | Units on a Scale | MEAN |
| SECONDARY | Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Visit 2 (Baseline) to Visit 6 (Week 4) | 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. | Units on a Scale | MEAN |
| PRIMARY | Mean Neuropathic Pain Score at Visit 4 (Week 2) | Visit 4 (Week 2) | 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. | Units on a Scale | MEAN |
| PRIMARY | Mean Neuropathic Pain Score at Visit 5 (Week 3) | Visit 5 (Week 3) | 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. | Units on a Scale | MEAN |
| PRIMARY | Mean Neuropathic Pain Score at Visit 6 (Week 4) | Visit 6 (Week 4) | 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. | Units on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Neuropathic Pain Score at Visit 3 (Week 1) | Gabapentin | 51.00 | Standard Deviation 17.39 | Units on a Scale | |
| Mean Neuropathic Pain Score at Visit 3 (Week 1) | MF0434 + Gabapentin | 50.70 | Standard Deviation 16.67 | Units on a Scale | |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Gabapentin | Baseline (Visit 2): General SF-36 QoL Index | 53.044 | Standard Deviation 22.409 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | MF0434 + Gabapentin | Baseline (Visit 2): General SF-36 QoL Index | 56.507 | Standard Deviation 19.523 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Gabapentin | Week 1 (Visit 3): General SF-36 QoL Index | 65.779 | Standard Deviation 20.882 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | MF0434 + Gabapentin | Week 1 (Visit 3): General SF-36 QoL Index | 65.610 | Standard Deviation 18.599 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Gabapentin | Week 2 (Visit 4): General SF-36 QoL Index | 69.531 | Standard Deviation 18.987 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | MF0434 + Gabapentin | Week 2 (Visit 4): General SF-36 QoL Index | 74.370 | Standard Deviation 15.595 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | Gabapentin | Week 3 (Visit 5): General SF-36 QoL Index | 73.058 | Standard Deviation 18.102 | Units on a Scale |
| Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire | MF0434 + Gabapentin | Week 3 (Visit 5): General SF-36 QoL Index | 78.075 | Standard Deviation 15.819 | Units on a Scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 38 | |
| Overall Study | STARTED | MF0434 + Gabapentin | 37 | |
| Overall Study | COMPLETED | Gabapentin | 38 | |
| Overall Study | COMPLETED | MF0434 + Gabapentin | 37 | |
| Overall Study | NOT COMPLETED | Gabapentin | 0 | |
| Overall Study | NOT COMPLETED | MF0434 + Gabapentin | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | Nervous system disorders | Gabapentin | 13 | 38 | |
| other | Drowsiness | Nervous system disorders | MF0434 + Gabapentin | 6 | 37 | |
| other | Dizziness | Nervous system disorders | Gabapentin | 12 | 38 | |
| other | Dizziness | Nervous system disorders | MF0434 + Gabapentin | 20 | 37 | |
| other | Headache | Nervous system disorders | Gabapentin | 3 | 38 | |
| other | Headache | Nervous system disorders | MF0434 + Gabapentin | 4 | 37 | |
| other | Hypoglycemia | Metabolism and nutrition disorders | Gabapentin | 2 | 38 | |
| other | Hypoglycemia | Metabolism and nutrition disorders | MF0434 + Gabapentin | 1 | 37 | |
| other | Lower Limb Edema | General disorders | Gabapentin | 1 | 38 | |
| other | Lower Limb Edema | General disorders | MF0434 + Gabapentin | 2 | 37 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, all-cause mortality | MF0434 + Gabapentin | ||
| Total, other adverse events | Gabapentin | 22 | 38 |
| Total, other adverse events | MF0434 + Gabapentin | 23 | 37 |
| Total, serious adverse events | Gabapentin | 0 | 38 |
| Total, serious adverse events | MF0434 + Gabapentin | 0 | 37 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gabapentin vs MF0434 + Gabapentin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01263132
GET https://conductscience.org/api/trials/v1/NCT01263132/events?page=2