Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Trevi Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nodularis Prurigo; Prurigo Nodularis; Prurigo; Pruritus

Treatments: Drug: Placebo tablets BID; Drug: nalbuphine HCl ER tablets 90 mg BID; Drug: nalbuphine HCl ER tablets 180 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02174419

TR03

2013-005627-17 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject suffering from generalized prurigo nodularis
• Have demonstrated pruritus intensity during screening
• Male or female who are at least 18 years old at the time of consent

Exclusion criteria

• Subject has chronic pruritus resulting from other conditions
• Subject has a history of substance abuse within the past year
• Subject has a known drug allergy to opioids
• Subject is a pregnant or lactating female

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

62 participants in 3 patient groups, including a placebo group

nalbuphine HCl ER 90mg

Experimental group

Description:

nalbuphine HCl ER tablets 90 mg BID

Treatment:

Drug: nalbuphine HCl ER tablets 90 mg BID

nalbuphine HCl ER 180 mg

Experimental group

Description:

nalbuphine HCl ER tablets 180 mg BID

Treatment:

Drug: nalbuphine HCl ER tablets 180 mg BID

Sugar pill

Placebo Comparator group

Description:

Placebo tablets BID

Treatment:

Drug: Placebo tablets BID