Phase 4
N=353
Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management
Diabetic Peripheral Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01364298 ↗Enrolled (actual)
353
Serious AEs
0.3%
Results posted
Feb 2014
Primary outcome: Primary: Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84 — 6.7; 6.8; 3.905; 4.260 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin/B-complex (Drug); Pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84 |
6.7; 6.8; 3.905; 4.260 | — |
| SECONDARY Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84 |
16.2; 15.8; 8.082; 6.967 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84 |
7.0; 7.1; 4.182; 4.529 | — |
| SECONDARY Profile of Mood States (POMS) Score |
1.3; 3.4 | — |
| SECONDARY Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration |
85; 72; 33; 33; 13; 12 | — |
| SECONDARY Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale |
62; 47; 73; 65; 10; 10 | — |
| SECONDARY Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale |
55; 47; 79; 69; 11; 6 | — |
| SECONDARY Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12) |
76.9; 85.4; 66.0; 72.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
80; 93 | — |
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 (= =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) = =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
Data sourced from ClinicalTrials.gov (NCT01364298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.