Clinical Trial: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial

Brief Summary: The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine

Detailed Summary:
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: Complete headache relief [ Time Frame: At 2 hours after first dose ]

The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete headache relief [ Time Frame: At 0.5 hour, 1 hour, and 4 hours after first dose ]
    The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.
  • Headache improvement. [ Time Frame: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose. ]
    The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
  • Using the second dose of study medications. [ Time Frame: At 2-48 hours after first dose. ]
    The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours
  • Using rescue medication between 2 and 48 hours postdose [ Time Frame: At 4-48 hours after second dose. ]
    The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3.
  • Rate of headache recurrence [ Time Frame: At 2-48 hours after first dose. ]
    The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours.
  • Occurrence of adverse events. [ Time Frame: At 4 hours after first dose. ]
    Presence or absence of adverse events occurred 4 hours after first dosing.


Original Secondary Outcome:

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: March 14, 2013
Date Started: January 2013
Date Completion:
Last Updated: July 28, 2013
Last Verified: July 2013