Experimental Biomarker Study for Pain Thresholds

NCT ID: NCT02695745

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-01-31

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

V116517

V116517 aqueous suspension; 300 mg

Group Type: EXPERIMENTAL

V116517 aqueous suspension

Intervention Type: DRUG

300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose

Placebo

Intervention Type: DRUG

Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose

Capsaicin

Intervention Type: DRUG

1% administered topically

Celecoxib

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

Group Type: ACTIVE_COMPARATOR

Celecoxib capsules

Intervention Type: DRUG

400 mg (2 capsules of 200 mg each) taken orally x 1 dose

Placebo

Intervention Type: DRUG

Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose

Capsaicin

Intervention Type: DRUG

1% administered topically

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose

Capsaicin

Intervention Type: DRUG

1% administered topically

Interventions

V116517 aqueous suspension

300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose

Intervention Type: DRUG

Celecoxib capsules

400 mg (2 capsules of 200 mg each) taken orally x 1 dose

Intervention Type: DRUG

Placebo

Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose

Intervention Type: DRUG

Capsaicin

1% administered topically

Intervention Type: DRUG

Other Intervention Names

Celebrex®; Celebra®

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CCBR A/S

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

2011-002399-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VND1004

Identifier Type: -

Identifier Source: org_study_id