Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000559718
Ethics application status
Approved
Date submitted
14/05/2013
Date registered
17/05/2013
Date last updated
25/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregabalin versus Gabapentin in the Treatment of Sciatica
Scientific title
Pregabalin versus Gabapentin for the Treatment of Sciatica: A Randomised, Double-Blind, Cross-over Study.
Secondary ID [1] 282501 0
NIL
Universal Trial Number (UTN)
Trial acronym
PAGPROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sciatica 289156 0
Condition category
Condition code
Neurological 289482 289482 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sequence 1 = Pregabalin capsules 150mg – initially 1 capsule daily for 1 week increasing to 1 capsule three times a day for 1 week then increase to 2 capsules three times a day thereafter. Treatment duration will be 8 weeks in total with drug tablet returns to be used to monitor compliance along with accountability logs. This will be followed by a 1 week washout period and then Gabapentin 400mg capsules in the identical titration method for a further 8 weeks treatment.
Intervention code [1] 287155 0
Treatment: Drugs
Comparator / control treatment
Sequence 2 = Gabapentin capsules 400mg – initially 1 capsule daily for 1 week increasing to 1 capsule three times a day for 1 week then increase to 2 capsules three times a day thereafter. Treatment duration will be 8 weeks in total with drug tablet returns to be used to monitor compliance along with accountability logs. This will be followed by a 1 week washout period and then Pregabalin 150mg capsules in the identical titration method for a further 8 weeks treatment.
Control group
Active

Outcomes
Primary outcome [1] 289585 0
To determine the efficacy of pregabalin compared to gabapentin in the treatment of sciatica.
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.
Timepoint [1] 289585 0
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 [1] 302781 0
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.
Timepoint [1] 302781 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double-blind, with double dummy method to maintain allocation concealment due to differences in dosing. Medications will be identical stored in identical containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence using a permuted block with varying block size and a ratio of 1:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
reached pre-set stopping rules
Date of first participant enrolment
Anticipated
8/03/2016
Actual
10/03/2016
Date of last participant enrolment
Anticipated
4/06/2018
Actual
2/11/2017
Date of last data collection
Anticipated
Actual
3/01/2018
Sample size
Target
38
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4389 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 287283 0
Hospital
Name [1] 287283 0
Private Practice Trust Fund - The Townsville Hospital
Country [1] 287283 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814
Country
Australia
Secondary sponsor category [1] 286037 0
None
Name [1] 286037 0
Address [1] 286037 0
Country [1] 286037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289261 0
The Townsville Health Service District Human Research Ethics Committee
Ethics committee address [1] 289261 0
The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814
Ethics committee country [1] 289261 0
Australia
Date submitted for ethics approval [1] 289261 0
19/06/2013
Approval date [1] 289261 0
04/10/2013
Ethics approval number [1] 289261 0
HREC/13/QTHS/117

Summary
Brief summary
Sciatica or sciatic neuralgia, a common form of lumbosacral radiculopathy, is characterized by low back pain that radiates to the leg below the knee and can be accompanied by sensory loss, motor weakness and reflex abnormalities. Sciatica is considered to be a prognostic indicator of poor outcome among patients with low back pain with a substantial proportion continuing to have persistent pain for two years or longer. The annual prevalence of sciatica is estimated to be between 14% and 2%. While guidelines provide clear and generally consistent recommendations for the prescription of drugs for non-specific low back pain this is not the case for sciatica.

Patients with a clinical diagnosis of sciatica are about five times more likely to take drugs than those with low back pain only, with analgesic and adjuvant pain drugs being the mainstay of current treatment. The efficacy of these prescribed medications is varied and conflicting in this population. Gabapentin and Pregabalin represent a newer approach to the treatment of sciatica. Both are analgesics of GABA that modulate the calcium-channel subunits, possibly decreasing the neurotransmitter release associated with the central sensitization that occurs in sciatica.

With the recent PBS listing of Pregabalin for neuropathic pain refractory to treatment with other drugs, we hypothesize pregabalin to be superior to gabapentin in reduction of pain for patients suffering sciatica. This head to head clinical trial will examine the effects of both agents in treating pain associated with sciatica compared to placebo in a randomised controlled setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40042 0
A/Prof Laurence Marshman
Address 40042 0
The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814
Country 40042 0
Australia
Phone 40042 0
+61 7 4433 1111
Fax 40042 0
Email 40042 0
l.a.g.marshman@btinternet.com
Contact person for public queries
Name 40043 0
Mr Kelvin Robertson
Address 40043 0
The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814
Country 40043 0
Australia
Phone 40043 0
+61 7 4433 1111
Fax 40043 0
Email 40043 0
kelvin.robertson@health.qld.gov.au
Contact person for scientific queries
Name 40044 0
A/Prof Laurence Marshman
Address 40044 0
The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814
Country 40044 0
Australia
Phone 40044 0
+61 7 4433 1111
Fax 40044 0
Email 40044 0
l.a.g.marshman@btinternet.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Gabapentin vs Pregabalin on Pain Intensity in Adults with Chronic Sciatica: A Randomized Clinical Trial.2019https://dx.doi.org/10.1001/jamaneurol.2018.3077
EmbasePregabalin versus gabapentin in the treatment of sciatica: Study protocol for a randomised, double-blind, cross-over trial (PAGPROS).2018https://dx.doi.org/10.1186/s13063-017-2400-y
N.B. These documents automatically identified may not have been verified by the study sponsor.