Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Diabetic Peripheral Neuropathic Pain

Treatments

Drug: Pregabalin

Drug: Gabapentin/B-complex

Study type

Interventional

Funder types

Industry

Identifiers

NCT01364298

EMR200054-603 CL028

Details and patient eligibility

About

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.

Full 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.

The duration of treatment per subject will be 12 weeks.

Enrollment

353 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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