ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

PAGPROS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sciatica

Condition category

Condition code

Neurological

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Private Practice Trust Fund - The Townsville Hospital

Address [1]

The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Health Service District Human Research Ethics Committee

Ethics committee address [1]

The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/06/2013

Approval date [1]

04/10/2013

Ethics approval number [1]

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

A/Prof Laurence Marshman

Address

The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

l.a.g.marshman@btinternet.com

Contact person for public queries

Name

Kelvin Robertson

Address

The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

kelvin.robertson@health.qld.gov.au

Contact person for scientific queries

Name

Laurence Marshman

Address

The Townsville hospital
100 Angus Smith Drive
Douglas Queensland 4814

Country

Australia

Phone

+61 7 4433 1111

Fax

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

Source	Title	Year of Publication	DOI
Embase	Pregabalin versus gabapentin in the treatment of sciatica: Study protocol for a randomised, double-blind, cross-over trial (PAGPROS).	2018	https://dx.doi.org/10.1186/s13063-017-2400-y
Embase	Effect of Gabapentin vs Pregabalin on Pain Intensity in Adults with Chronic Sciatica: A Randomized Clinical Trial.	2019	https://dx.doi.org/10.1001/jamaneurol.2018.3077

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically