A Phase 3 interventional study of Paracetamol (acetaminophen) and Paracetamol Placebo in Headache, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
Tension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headaches per month), and chronic TTH (15 headache days a month or more). Paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.Objectives To assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic TTH in adults.
Headaches are a commonly reported problem in community-based surveys worldwide. The lifetime prevalence of headache is estimated to be greater than 90% , and the annual prevalence rate is estimated to be 46% in the general adult population . Variations in reported prevalence may result from differences in study design, population, inclusion or exclusion of cases of infrequent episodic TTH, overlap with probable migraine, cultural and environmental differences, or even genetic factors . TTH is more common than migraine, a finding replicated across the work.
The management of people with headaches is largely neglected , and may be fragmented by the involvement of clinicians from different medical specialities (neurology; ear, nose and throat; ophthalmology; psychiatry). Because headache is rarely life-threatening and headache pain is generally mild to moderate in intensity, people often self medicate and do not seek formal care from health services .
Headache can be either primary (no underlying cause) or secondary (due to other systemic or local causes) . TTH belongs to the group of primary headaches and is seen in nearly one-third of people experiencing headaches; the large number of people affected imposes a significant burden on the healthcare system. Generally, episodes of TTH are mild to moderate in intensity, and self limiting, but in a small group of people they may be more severe and disabling . People with longer lasting or more severe headaches may seek help in a clinical setting, but the majority of people do not do so, resulting often in inadequate and inappropriate management .
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients will recive paracetamol
Drug: Paracetamol (acetaminophen)
patients will recive placebo
Drug: Paracetamol Placebo
oral paracetamol 500mg three times per day
placebo tab three time per day
pain score VAS score
VAS Score for pain
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Assiut University