Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001052224
Ethics application status
Approved
Date submitted
14/12/2017
Date registered
25/06/2018
Date last updated
25/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison in efficacy of carbamazepine, oxcarbazepine and baclofen in the management of trigeminal neuralgia: a double blinded randomised clinical trial
Scientific title
Comparison in efficacy of carbamazepine, oxcarbazepine and baclofen in the management of trigeminal neuralgia: a double blinded randomised clinical trial
Secondary ID [1] 293297 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trigeminal neuralgia 305378 0
Psychogenic pain 305379 0
Condition category
Condition code
Oral and Gastrointestinal 304663 304663 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 304664 304664 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double blinded randomised control trial will be conducted in oral and maxillofacial surgery department of Islamic International Dental College Islamabad. There will be three groups. An independent researcher "X" will do randomisation. He will prescribe one of three drugs for 1 month ( carbamazipine upto 1200 mg, oxcarbazipine upto 1200 mg or baclofen upto 30 mg). He will prescribe one of three drugs daily for one month. Doses may vary.Patient will self administer the drug in form of oral tablet. Other investigators Dr. A or B ( unaware of the drug prescribed by Dr. X) will take patients VAS before the commencement of treatment and will take VAS score again after three months. Every participant will receive only one drug
To evaluate the side effects of drugs and monitor adherence to drug, record will be taken before starting and after 1 month of therapy. Heamotological and hepatic enzymes will be evaluated by lab test.
Intervention code [1] 299555 0
Treatment: Drugs
Comparator / control treatment
Arm 3 will be active control.
Arm 1 carbamazipine 1200 mg per day orally
Arm 2 oxcarbazipine 1200 mg per day orally
Arm 3 baclofen 30 mg per day orally ( active control)
Control group
Active

Outcomes
Primary outcome [1] 304240 0
Pain as assessed using VAS
Timepoint [1] 304240 0
A day before treatment
One month after commencement of treatment
Secondary outcome [1] 341340 0
Blood levels (rbcs) will be assessed with the haemotological test and clinical signs
Timepoint [1] 341340 0
A day before treatment
One month after treatment
Secondary outcome [2] 348108 0
Composite Lfts will be assessed by laboratory method serum assay
Timepoint [2] 348108 0
One month after the commencement of treatment

Eligibility
Key inclusion criteria
a. Patients with trigeminal neuralgia.
b. Patients above 18 years
c. Patients who have sufficient cognitive function
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patient already taking any other kind of medication for the treatment of neuralgia
b. Patients who have undergone surgical procedure for management of Trigeminal Neuralgia.
c. Patients who have hypersensitivity to carbamazepine, oxcarbazepine or baclofen.
d. Patients with acute or chronic liver or renal failure.
e. Patients who were on drugs that may affect cognitive function e.g. psychiatric drugs including tricyclic antidepressants.
f. Patients who were not willing for follow up.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
30/07/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 9436 0
Pakistan
State/province [1] 9436 0

Funding & Sponsors
Funding source category [1] 297921 0
Self funded/Unfunded
Name [1] 297921 0
Mohsin Fazal
Country [1] 297921 0
Pakistan
Primary sponsor type
Individual
Name
Mohsin Fazal
Address
Islamic international dental hospital Muhammad Mansha Yaad Rd, G-7/4 Islamabad, Islamabad Capital Territory, Pakistan
Country
Pakistan
Secondary sponsor category [1] 296983 0
None
Name [1] 296983 0
Address [1] 296983 0
Country [1] 296983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298969 0
Islamic International Dental Hospital Ethical Committee
Ethics committee address [1] 298969 0
Ethics committee country [1] 298969 0
Date submitted for ethics approval [1] 298969 0
Approval date [1] 298969 0
06/12/2017
Ethics approval number [1] 298969 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78834 0
A/Prof Mohsin Fazal
Address 78834 0
Islamic international dental hospital Muhammad Mansha Yaad Rd, G-7/4 Islamabad, Islamabad Capital Territory, Pakistan
Country 78834 0
Pakistan
Phone 78834 0
+92512891835
Fax 78834 0
Email 78834 0
Mohsin.fazal@riphah.edu.pk
Contact person for public queries
Name 78835 0
Mohsin Fazal
Address 78835 0
Islamic international dental hospital Muhammad Mansha Yaad Rd, G-7/4 Islamabad, Islamabad Capital Territory, Pakistan
Country 78835 0
Pakistan
Phone 78835 0
+ 92 51 2891835
Fax 78835 0
Email 78835 0
Mohsin.fazal@riphah.edu
Contact person for scientific queries
Name 78836 0
Mohsin Fazal
Address 78836 0
Islamic international dental hospital Muhammad Mansha Yaad Rd, G-7/4 Islamabad, Islamabad Capital Territory, Pakistan
Country 78836 0
Pakistan
Phone 78836 0
+92 51 2891835
Fax 78836 0
Email 78836 0
Mohsin.fazal@riphah.edu

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
No additional documents have been identified.