Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prurigo Nodularis Nodularis Prurigo Prurigo Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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nalbuphine HCl ER 90mg

nalbuphine HCl ER tablets 90 mg BID

Group Type EXPERIMENTAL

nalbuphine HCl ER tablets 90 mg BID

Intervention Type DRUG

nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks

nalbuphine HCl ER 180 mg

nalbuphine HCl ER tablets 180 mg BID

Group Type EXPERIMENTAL

nalbuphine HCl ER tablets 180 mg BID

Intervention Type DRUG

nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks

Sugar pill

Placebo tablets BID

Group Type PLACEBO_COMPARATOR

Placebo tablets BID

Intervention Type DRUG

Placebo tablets BID administered for 10 weeks

Interventions

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nalbuphine HCl ER tablets 90 mg BID

nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks

Intervention Type DRUG

nalbuphine HCl ER tablets 180 mg BID

nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks

Intervention Type DRUG

Placebo tablets BID

Placebo tablets BID administered for 10 weeks

Intervention Type DRUG

Other Intervention Names

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nalbuphine ER nalbuphine ER sugar pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No