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Completed

NCT Number: NCT02695745

Experimental Biomarker Study for Pain Thresholds

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CCBR A/S

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include:

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

Exclusion criteria

include:

  • Current or recent (within 5 years) history of drug or alcohol abuse.
  • History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
  • Any history of frequent nausea or emesis regardless of etiology.
  • 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.
  • 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.

Treatment and study plan

V116517 aqueous suspension

Drug

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

Celecoxib capsules

Drug

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

Other names: Celebrex®, Celebra®

Placebo

Drug

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

Capsaicin

Drug

1% administered topically

Primary outcomes

  1. Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application

    Time frame: 3.5 hours post-dose

    Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm

Secondary outcomes

  1. Heat Pain Threshold (HPTr)

    Time frame: 3.5 hours post-dose

    Mean temperature in degrees Celsius (°C)

  2. Heat Pain tolerance threshold (HPTolTr)

    Time frame: Pre-dose and 3.5 hours post-dose

    Mean temperature in degrees Celsius (°C)

  3. Pressure Pain Threshold (PPTr)

    Time frame: 3.5 hours post-dose

    Mean pressure kPA

  4. Pressure Pain tolerance threshold (PPTolTr)

    Time frame: 3.5 hours post-dose

    Mean pressure kPA

  5. Peripheral nociceptor activation using Laser Doppler flowmetry

    Time frame: 3.5 hours post-dose

    Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging

  6. Erythema at the treated area using Erythema index

    Time frame: 3.5 hours post-dose

    Erythema at the treated area will be assessed using colorimetry

  7. Stimulus-response function to graded von Frey hair stimulation

    Time frame: 3.5 hours post-dose

    The mean pain intensity of the stimulations on a '0-10' visual analog scale (VAS), where '0' indicates ''no pain" and '10' indicates '' the most intense pain imaginable''

  8. Secondary pin-prick hyperalgesic area

    Time frame: 3.5 hours post-dose

    The area will be assessed using a 60 g weighted von Frey hair, and subjects are asked to report when the sensation changes to a "different sensation", "unpleasant" or "burning pain" sensation

  9. Evaluation of change in body temperature

    Time frame: Pre-dose and up to 72 hours post-dose

    Oral temperature in degrees Celsius (˚C)

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study title

Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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