albuphine HCL ER Tablets in Prurigo Nodularis Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients with prurigo nodularis who completed the TR03 study and have met Inclusion/Exclusion eligibility requirements for TR03ext:

1. Have been adequately informed of the nature and risks of the study and have given written informed consent at the conclusion of TR03 Visit 6 and prior to Visit 1a.
2. Have completed participation in the TR03 study.
Completion of participation in the TR03 study is defined as completion of Study Drug treatment through TR03 Visit 5 and completion of the TR03 Visit 6.
3. Agree to comply with the contraception requirements set by the protocol
4. Ability and acceptance to provide written informed consent.
5. Willing and able to comply with study requirements and restrictions
6. Agree to the confidential use and storage of all data (including photography) and use of all anonymized data for publication including scientific publication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Patients with a history of congestive heart failure of Class 2 or higher
as graded using the New York Heart Association scale (scale provided in
Appendix 5)
2. Patients with a history of angina pectoris grade 2 or higher as graded
using the Canadian Cardiovascular Society grading scale (scale provided
in Appendix 5)
3. History of ventricular tachycardia, torsade de pointes, family history
of sudden death, myocardial infarction or acute coronary syndrome
within the previous 3 months, as reported by the patient.
4. Serum potassium below the laboratory lower limit of normality at
TR03 visit 5. Note: Potassium levels below the laboratory lower limit of
normal at Visit 6 /Visit 1a should be repeated and potassium
supplementation provided as appropriate
5. QTcF interval >450ms on screening / Visit 1a EKG
6. Heart rate <50 BPM on any screening measurement. Patient with a
resting heart rate of <50 bpm will have it repeated once after 5 minutes
in the supine position, and if it remains <50 bpm during the repeat, they
will be considered a screen failure.
7. Use of a medication known to be associated with risk of torsade de
pointes (see Section 9.7.8, Safety Assessments, for hyperlink to the
CredibleMeds Filtered QTDrug List for cardiovascular related prohibited
medications with a known associated risk of Torsade de Pointes)
8. History of substance abuse within the past year as determined by the
Investigator
9. Significant medical condition or other factors that in the opinion of the
Investigator may interfere with the conduct of the study
10. Known hypersensitivity or allergy to nalbuphine or formulation
components
11. Is a pregnant or lactating female.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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