Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Gabapentin/B-complex; Pregabalin
Intervention description: 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).; 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).
Intervention MeSH terms: Pregabalin; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Gabapentin/B complex; Pregabalin; Pain; Neuropathic; Gavindo; Lyrica

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females or males undististincally

          -  Age 18 to 70 years

          -  Signed informed consent (IC) by the subject

          -  Diabetes mellitus (DM) Type 1 or 2

          -  Pain due to sensorial or motor DPN of low to moderate intensity, greater than or equal
             to (>=) 1 year of evolution and less than or equal to (=<)5 years of being diagnosed

          -  Subjects who score >=40 millimeter (mm) in the visual analogue scale (VAS) of the
             McGill pain questionnaire (MPQ) at selection and Baseline visit, and who complete on a
             daily basis the numeric pain intensity (NPI) (at least 4 days a week) during the week
             previous to randomization and whose daily mean score is of at least 4, during the 7
             days previous to randomization (with a wash-out period)

          -  Normal chest radiography

          -  Stable hypoglycemic treatment, at least 6 weeks before randomization

          -  Glycosylated hemoglobin (HbA1c) =<10 percent at selection visit

          -  Women must not be pregnant and must not have pregnancy plans during the period of the
             study duration

          -  Subjects not medicated or under analgesic stable medication during a minimum of 4
             weeks, where no acceptable relief of pain is achieved; in the last case, with the
             corresponding wash-out period

          -  Women of childbearing age must submit a negative pregnancy test before treatment
             randomization and should use a contraceptive method medically accepted, during the
             study period

        Exclusion Criteria:

          -  Suicide risk defined as a score of 2 or higher, in question 9 of the beck depression
             test

          -  Congestive heart failure Class III or IV of the New York Heart Association (NYHA)

          -  Subjects with serious or unstable coronary heart disease, hepatic, kidney,
             respiratory, hematological alterations, problems with peripheral vascular disease, or
             other medical or psychiatric conditions that can put in risk the participation of the
             subject in the study or that may lead to hospitalization during the study period

          -  Any condition that may lead to confusion of the diagnostic of painful DPN, in
             particular amputations -other than fingers/toes-, not diabetic neurological disorder
             and skin conditions that may affect sensation at the painful limbs

          -  Subjects with Baseline calculated creatinine clearance less than (<) 60 milliliter per
             minute (mL/min), Baseline leukocyte count < 2,500 per cubic millimeter (/mm^3),
             Baseline neutrophils count < 1,500/mm^3 or platelets < 100 * 10^3 /mm^3

          -  Subjects who have participated previously in some other study of pregabalin or
             gabapentin or gabapentin/B-complex, during 30 days previous to selection

          -  Subjects with encephalopathy caused by ammonia with alterations in the cycle of urea

          -  Subjects with uncontrolled closed-angle glaucoma

          -  Subject with presence of a disorder or an anticonvulsant treatment

          -  Breastfeeding women or during the first 3 months postpartum

          -  Morbid obesity (body mass index [BMI] >=40)

          -  Glycosylated hemoglobin (HbA1c) greater than (>) 10 percent

          -  Major surgery 3 months previous to randomization

          -  Any surgery 2 weeks previous to randomization process, or programmed during the study
             period should have been authorized by the Sponsor or appointed representative

          -  Blood donors 60 days previous to randomization

          -  Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances,
             or energizing drinks

          -  History of hypersensitivity to the drugs in the study or drugs with similar chemical
             structures

          -  History or suspicion of lack of trust, poor cooperation of lack of compliance of
             medical treatments

          -  Subjects with arthritis, sciatic, fibromyalgia, restless leg syndrome, non-neuropathic
             muscle-skeletal pain or back chronic pain