NCT02193620 - Study of PHN131 in Patients After Surgery | Biotech Hunter

Enrollment

106

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

September 21, 2014

Study Completion Date

February 13, 2019

Conditions

Analgesia Disorder

Interventions

DRUG

PHN131 soft capsule with Nalbuphine HCl 60 mg/cap

Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.

DRUG

Placebo soft capsules

Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.

DRUG

Dicofenac

All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.

Trial Locations (1)

General Clinical Research Center, Tri-service General Hospital, Taipei