Celecoxib has not been abuse widely as a pain relief drug for headache. Our aim of this study was Comparison between Celecoxib and Prednisolone in bridge stage therapy following medication overuse headache. Double-blind randomized clinical trial was done in patients admitted to a private headache clinic in Tehran; Iran at 2012. Patients with 18-65 years old with > 15 days headache per month were studied. Prednisone as a 75mg, 50 mg, 30 mg, 25 mg and 10 mg/day (every 3 days) and celexcib as a 100mg three times, twice and one time/day (every 5 days) was administered. Headache days, headache intensity, headache duration, analgesic consumption due to severe headaches and drug side effects were assessed. Was used the visual analog scale to determine the severity of the pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061211560N6
Registration date:2013-09-10, 1392/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-10, 1392/06/19
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Celecoxib and Prednisolone in bridge stage therapy following medication overuse headache
Public title
Withdrawal treatment in medication overuse headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18-65 years old; headache more than 15 days per month; regular using of two drugs or more for symptomatic therapy more than 3 month; progressive headache; no underlying disease; no pregnancy.
Exclusion criteria: no follow up and stopping of using drugs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Hemat gateway, Central devision of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
91/d/130/1428
Health conditions studied
1
Description of health condition studied
Medication Overuse Headache
ICD-10 code
G44.4
ICD-10 code description
Drug-induced headache
Primary outcomes
1
Description
Headache time
Timepoint
Start of treatment, 2 weeks following start of treatment
Method of measurement
Hour
2
Description
Headache
Timepoint
Start of treatment, 2 weeks following start of treatment
Method of measurement
Visual Analogue Scale
3
Description
Headache days
Timepoint
Start of treatment, 2weeks following start of treatment
Method of measurement
Days
Secondary outcomes
1
Description
Drug adverse reaction
Timepoint
Start of treatment, 2 weeks following start of treatment
Method of measurement
Hstory
Intervention groups
1
Description
Prednisone as a 75mg, 50 mg, 30 mg, 25 mg and 10 mg/day (every 3 days)
Category
Treatment - Drugs
2
Description
Celexcib as a 100mg three times, twice and one time/day (every 5 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Elahe Taghvaii Zahmat kesh, Neurology assistant
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
1428/130/د/91
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Elahe Taghvaii Zahmat kesh
Position
Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
elahetaghvaii@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Elahe Taghvaii Zahmat kesh
Position
Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
elahetaghvaii@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Elahe Taghvaii Zahmat kesh
Position
Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
elahetaghvaii@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)