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

NCT01364298 | Completed Phase 4 Results DMC

• 1 other identifier: EMR200054-603 CL028
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Gabapentin/B complex; Pregabalin; Pain; Neuropathic; Gavindo; Lyrica

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84

  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.

  Baseline and Day 84 (Week 12)

Secondary Outcomes (8)

• 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)

Study Arms (2)

Gabapentin/B-complex

EXPERIMENTAL

Drug: Gabapentin/B-complex

Pregabalin

ACTIVE COMPARATOR

Drug: Pregabalin

Interventions

Gabapentin/B-complex DRUG

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).

Also known as: Gavindo®

Gabapentin/B-complex

Pregabalin DRUG

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).

Also known as: Lyrica®

Pregabalin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck S.A. de C.V., Mexico: collaborator

Study Sites (1)

Research Site

Mexico City, Mexico

Location

Related Publications (1)

• Mimenza Alvarado A, Aguilar Navarro S. Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy. J Diabetes Res. 2016;2016:4078695. doi: 10.1155/2016/4078695. Epub 2016 Jan 17.

  PMID: 26885528 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Clinical Research Manager

  Merck S.A de C.V, Mexiko, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2013-12

Locations

ME (1)