Evaluate the comparative effectiveness of three therapeutic drug regimen for the treatment of a withdrawal headache in patients with medication overuse headache, referring to the neurology clinic
comparing the effect of three therapeutic drug regimen for the treatment of a withdrawal headache in patients with medication overuse headache
Design
The randomized clinical trial with three groups
Settings and conduct
The study will be conducted as a randomized clinical trial. Participants in the study will be among patients referred to a neurology clinic of Imam Khomeini Hospital in Urmia in 2018. The patients with identified headache under the title of MOH will be included based on the inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with ages18 to 50 years old, no specific disease history, no pregnancy, patients with a headache more than 15 days in the month, regular use history of one or more medications for more than three months, lack of platelet disorders.
Exclusion Criteria: No referral for the upcoming follow-up, arbitrary discontinuation of the drug
Intervention groups
1-celexib group
2-prednisolon group
3-prednisolon plus celexib group
Main outcome variables
Headache severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041334N1
Registration date:2018-12-02, 1397/09/11
Registration timing:registered_while_recruiting
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Arash Mosarrezaii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
mosarrezaii.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the comparative effectiveness of three therapeutic drug regimen for the treatment of a withdrawal headache in patients with medication overuse headache, referring to the neurology clinic
Public title
Comparing the effectiveness of three therapeutic drug regimen for the treatment of a withdrawal headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to50 year
Patients with headache more than 15 days per month
A history of regular use of one or more symptomatic treatment medications over a period of more than a month, including ergotamine, tryptan, combination of analgesic drugs (simple and combination), tryptones, ergotamine and narcotics (more than 10 days per month for more than 3 months), or analgesic drugs Simple such as acetaminophen or NSAIDs (10 days per month in regular three months)
A headache that progresses or gets worse in the course of drug abuse
lack of mental psychological illness
no pregnancy
No previous history or disease has been detected
not having platelet disorders
Exclusion criteria:
lack of referral for the follow up
Arbitrary discontinuation of patient medication
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For each group, there will be 10 envelopes for men and 10 envelopes for women containing the group number (20 envelopes for each group). The Clinic Clerk will randomly pick up an envelope from one group for delivery to the eligible patient. For women, this should be the same. At the same time, one Female person within a group should be entered in parallel with one male one, until finally, 10 men and 10 women will be enrolled in the study within each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia Medical Science University Ethical committee
Street address
Resalat
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.UMSU.REC.1397.094
Health conditions studied
1
Description of health condition studied
Medication Overuse Headache (MOH)
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache severity
Timepoint
15 days
Method of measurement
VAS
2
Description
Headache duration
Timepoint
daily
Method of measurement
headache duration (days)
Secondary outcomes
1
Description
Drug dependence reduction
Timepoint
15 days
Method of measurement
Used Drug Dosage
Intervention groups
1
Description
Intervention group: celecoxib (100 mg, Cap, Iran, Tehran, Daru Pars, celecoxib 100 mg three times daily for the first five days, 100 mg twice daily (five days later) and 100 mg once a day (five The next day)
Category
Treatment - Drugs
2
Description
Intervention group: Prednisolone Tablets (Aburaihan Pharmaceutical, Iran, Tehran, .Co, 50 mg, 5 mg) 75 mg (three first days) 50 mg (three days later) 30 mg (three The next day (25 mg three days later) and 10 mg (the last 3 days)
Category
Treatment - Drugs
3
Description
Intervention group: celecoxib 100 mg three times daily + 75 mg prednisolone for the first 4 days, celecoxib 100 mg twice daily + 50 mg prednisolone for the second 4 days, celecoxib 100 mg once daily + 25 mg prednisolone for 4 days, 100 mg once daily + 10 mg prednisolone for 3 last day