Pregabalin versus Gabapentin in the Treatment of Sciatica

Phase 3

• Conditions: Sciatica; Neurological - Other neurological disorders

• Registration Number: ACTRN12613000559718
• Lead Sponsor: The Townsville Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

18 years or older
Diagnosis of sciatica
First presentation to the pain clinic for intervention treatment
Patients with continuous sciatica for over 3 months, with a corresponding physical cause proven on CT or MRI, will be considered.

Exclusion Criteria

Pregnant or breastfeeding
Prior treatment with pregabalin and or gabapentin
Clinically relevant medical/psychological illness which might affect study participation
Creatinine clearance <60ml/min
Taking antiepileptics, nerve blocks muscle relaxants, anticonvulsants, mexiletine, topical analgesics, or antiviral agents.
Patient history or laboratory results that suggested the presence of an inherited neuropathy or neuropathy attributable to other causes, such as hypothyroidism, vitamin B12 deficiency, connective tissue disease, amyloidosis, and toxic exposure
Major organ system disease, cardiovascular autonomic neuropathy, baseline postural hypotension of more than 20 mm Hg, sedation or ataxia due to concomitant drugs or other cause, urinary symptoms attributable to benign prostatic hypertrophy in male participants, psychiatric or substance abuse disorder, hypersensitivity to any of the study drugs, or a coexisting disorder causing pain as severe as the neuropathic pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of pregabalin compared to gabapentin in the treatment of sciatica.<br>Definition of efficacy is reduction of sciatic pain with measure on an 11-point numerical rating scale from 0=no pain to 10=worst possible pain by patient, assessment by blinded neurosurgeon.<br>[Primary outcome assessments will be made at baseline, after the first treatment period of 8 weeks and again at baseline in the second treatment phase and after the second treatment period of 8 weeks on the alternate medication. ]

Secondary Outcome Measures

Name	Time	Method
To determine the frequency and severity of common of side-effects associated with pregabalin and gabapentin including fatigue, sedation, dizziness, ataxia, tremor, diplopia, nystagmus, amblyopia, amnesia, abnormal thinking, hypertension, vasodilation, peripheral oedema, dry mouth, weight gain, rash.<br><br>[Secondary outcome assessments will be made at baseline, after the first treatment period of 8 weeks and again at baseline in the second treatment phase and after the second treatment period of 8 weeks on the alternate medication.]