Experimental Biomarker Study for Pain Thresholds

Purdue Pharma

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: V116517 aqueous suspension; Drug: Capsaicin; Drug: Celecoxib capsules; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02695745

VND1004

2011-002399-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

1. Signed informed consent obtained.
2. Males aged 18 to 45, inclusive.
3. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
4. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.

Exclusion Criteria include:

1. Current or recent (within 5 years) history of drug or alcohol abuse.
2. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
3. Any history of frequent nausea or emesis regardless of etiology.
4. Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.
5. Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.

Other protocol-specific inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 3 patient groups, including a placebo group

V116517

Experimental group

Description:

V116517 aqueous suspension; 300 mg

Treatment:

Drug: V116517 aqueous suspension

Drug: Placebo

Drug: Capsaicin

Celecoxib

Active Comparator group

Description:

Celecoxib capsules; 400 mg (2 capsules of 200 mg each)

Treatment:

Drug: Placebo

Drug: Celecoxib capsules

Drug: Capsaicin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Capsaicin