Who is sponsoring NCT02541396?

NCT02541396 is sponsored by iX Biopharma Ltd..

What condition does NCT02541396 study?

NCT02541396 studies Acute Pain.

What drugs are being tested in NCT02541396?

Interventions: Wafermine, Oxycodone, Placebo.

What is the status of NCT02541396?

NCT02541396 is currently COMPLETED.

Last reviewed 2016-02-22 · How we verify

A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

NCT02541396 Phase 2 COMPLETED

To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.

Details

Lead sponsor	iX Biopharma Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	72
Start date	2015-10
Completion	2015-12

Conditions

Acute Pain

Interventions

Wafermine
Oxycodone
Placebo

Primary outcomes

Total Pain Relief (TOTPAR) — 24 hours
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ \[T(i) - T(i-1) \* \[(PR(i-1) + PR(i))/2\]

Countries

United States