NCT01364298CompletedPhase 4
Multicenter, Randomized, Open-label, Parallel Group, Phase IV Study to Compare the Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in the Management of Diabetic Peripheral Neuropathic Pain
Merck KGaA, Darmstadt, Germany1 site in 1 country353 target enrollmentStarted: April 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 353
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84
Study Overview
Brief 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.
Detailed Description
Primary Objective:
To compare the efficacy of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate diabetic peripheral neuropathy (DPN) of acute or chronic presentation.
Secondary Objectives:
To determine the safety and tolerability of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate DPN of acute or chronic presentation.
Subjects will be randomized in a 1:1 ratio to receive gabapentin/B-complex or pregabalin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Gabapentin/B-complex
Experimental
Intervention: Gabapentin/B-complex (Drug)
Pregabalin
Active Comparator
Intervention: Pregabalin (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84
Time Frame: Baseline and Day 84 (Week 12)
An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.
Secondary Outcomes
- Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84(Baseline and Day 84 (Week 12))
- Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84(Baseline and Day 84 (Week 12))
- Profile of Mood States (POMS) Score(Day 84 (Week 12))
- Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration(Day 84 (Week 12))
- Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale(Baseline and Day 84 (Week 12))
- Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)(Baseline and Day 84 (Week 12))
- Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale(Baseline and Day 84 (Week 12))
- Number of Participants With Adverse Events (AEs)(Day 7 up to Day 84 (+7 days))
Investigators
Study Sites (1)
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