Trial Outcomes & Findings for IV Dexketoprofen vs Placebo in Migranie Attack (NCT NCT02159547)

Results Overview

Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

224 participants

Primary outcome timeframe

45 minutes

Results posted on

2015-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Dexketoprofen 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes	Normal Slaline 50 ml normal saline Normal Saline: 50 ml normal saline
Overall Study STARTED	112	112
Overall Study COMPLETED	112	112
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IV Dexketoprofen vs Placebo in Migranie Attack

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexketoprofen n=112 Participants 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes	Normal Slaline n=112 Participants 50 ml normal saline Normal Saline: 50 ml normal saline	Total n=224 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	37.6 years STANDARD_DEVIATION 10.7 • n=7 Participants	36.9 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	83 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Turkey	112 participants n=5 Participants	112 participants n=7 Participants	224 participants n=5 Participants

PRIMARY outcome

Timeframe: 45 minutes

Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.

Outcome measures

Outcome measures
Measure	Dexketoprofen n=112 Participants 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.	Normal Slaline n=112 Participants 50 ml normal saline Normal Saline: 50 ml normal saline
Visual Analogue Scale Change	55 units on a scale Interval 49.0 to 60.0	30 units on a scale Interval 25.0 to 35.0

SECONDARY outcome

Timeframe: 45th minutes

The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.

Outcome measures

Outcome measures
Measure	Dexketoprofen n=112 Participants 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.	Normal Slaline n=112 Participants 50 ml normal saline Normal Saline: 50 ml normal saline
Adverse Effects	0 participants	0 participants

Adverse Events

Dexketoprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Slaline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cenker EKEN

Akdeniz University

Phone: 00905321593948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place