Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02174419
Other study ID # TR03
Secondary ID 2013-005627-17
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 2015
Est. completion date August 2016

Study information

Verified date October 2020
Source Trevi Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
nalbuphine HCl ER tablets 180 mg BID
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Placebo tablets BID
Placebo tablets BID administered for 10 weeks

Locations

Country Name City State
Germany University of Münster Münster
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Wroclaw Dolnoslaskie
United States Case Western Reserve University Cleveland Ohio
United States Temple University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Trevi Therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale Baseline, Week 10
Primary Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated, Baseline, Week 10
Secondary Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale Baseline, Week 10
See also
  Status Clinical Trial Phase
Completed NCT05038982 - Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Phase 2
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
Terminated NCT01825655 - Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching Phase 4
Completed NCT01236859 - Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus N/A
Completed NCT00782054 - Evaluation of Post Burn Rehabilitation Population for Itch Control Phase 4
Completed NCT04999787 - A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus Phase 2
Recruiting NCT04256759 - Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Phase 2
Completed NCT04337073 - The Effect of Propofol on Dexamethasone-induced Perineal Pruritus Early Phase 1
Completed NCT04415034 - Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Active, not recruiting NCT05525520 - Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT04399525 - Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. N/A
Recruiting NCT02432508 - Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis N/A
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT01963793 - Topical Aprepitant in Prurigo Patients Phase 2
Completed NCT01232985 - Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults Phase 2
Not yet recruiting NCT00577967 - Gabapentin - A Solution to Uremic Pruritus? N/A
Recruiting NCT06120907 - Swiss Itch Registry
Recruiting NCT04589429 - Adding Nalbuphine for Control of Intrathecal Morphine Pruritus Phase 2