Neuropathic Pain Management

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDiabetic Neuropathies
Polyneuropathies
InterventionDrug: F0434
Drug: Gabapentin
PhasePhase 3
SponsorMerck KGaA
Responsible PartyMerck KGaA
ClinicalTrials.gov IdentifierNCT01263132
First ReceivedDecember 14, 2010
Last UpdatedJanuary 20, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateDecember 14, 2010
Last Updated DateJanuary 20, 2014
Start DateFebruary 2008
Estimated Primary Completion DateFebruary 2010
Current Primary Outcome Measures
  • Mean Neuropathic Pain Score at Visit 3 (Week 1) [Time Frame: Visit 3 (Week 1)] [Designated as safety issue: Yes]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.
  • Mean Neuropathic Pain Score at Visit 4 (Week 2) [Time Frame: Visit 4 (Week 2)] [Designated as safety issue: Yes]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.
  • Mean Neuropathic Pain Score at Visit 5 (Week 3) [Time Frame: Visit 5 (Week 3)] [Designated as safety issue: Yes]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.
  • Mean Neuropathic Pain Score at Visit 6 (Week 4) [Time Frame: Visit 6 (Week 4)] [Designated as safety issue: Yes]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.
Current Secondary Outcome MeasuresQuality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire [Time Frame: Visit 2 (Baseline) to Visit 6 (Week 4)] [Designated as safety issue: Yes]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.

Descriptive Information[ + expand ][ + ]

Brief TitleNeuropathic Pain Management
Official TitleNeuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
Brief Summary
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.
Detailed Description
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

- To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of
Life (QOL) of subjects with diabetic neuropathy through a current and validated
neuropathic pain scale along with the QOL questionnaire.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition
  • Diabetic Neuropathies
  • Polyneuropathies
InterventionDrug: F0434
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).
Other Names:
Gabapentin with thiamine and cobalaminDrug: Gabapentin
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)
Other Names:
  • Gababion
  • Gavindo
Study Arm (s)
  • Experimental: F0434
  • Active Comparator: Gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment104
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateFebruary 2010
Eligibility Criteria
Inclusion Criteria:

- Subjects diagnosed with diabetes mellitus type 2

- Subjects with a history of neuropathic pain in the last 3 Months

- Men and women in reproductive age with a family planning method

- Subjects aged between 18 to 70 years

- Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%

- Subjects that obtain a grade equal or greater than 4 in the visual analogue scale
during the screening visit

Exclusion Criteria:

- Subjects diagnosed as being pregnant or in state of lactation

- Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour
urine, less than 60mL/min

- Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are
taking vitamin B1 and B12 for treatment of neuropathic diabetes

- Subjects who are being pharmacologically treated for epilepsy

- Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy
for other causes

- Subjects with psychological and psychiatric alteration that hinders adequate
collaboration in the study

- Subjects with any orthopaedic alteration of any extremity

- Subjects with peripheral artery disease

- Subjects taking more than two neuropathic pain medicines

- Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance
abuse

- Subjects with acid-peptic disease

- Subjects with history of neoplasm of any type
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMexico

Administrative Information[ + expand ][ + ]

NCT Number NCT01263132
Other Study ID Numbers200057-500
Has Data Monitoring CommitteeNo
Information Provided ByMerck KGaA
Study SponsorMerck KGaA
CollaboratorsMerck S.A. de C.V., Mexico
Investigators Study Director: Medical Director Merck S.A. de C.V., Mexico
Verification DateJanuary 2014

Locations[ + expand ][ + ]

REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
Pachuca, Hidalgo, Mexico, 42090