NCT02695745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 22, 2016

Last Update Submit

February 24, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

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

    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

    3.5 hours post-dose

Secondary Outcomes (9)

  • Heat Pain Threshold (HPTr)

    3.5 hours post-dose

  • Heat Pain tolerance threshold (HPTolTr)

    Pre-dose and 3.5 hours post-dose

  • Pressure Pain Threshold (PPTr)

    3.5 hours post-dose

  • Pressure Pain tolerance threshold (PPTolTr)

    3.5 hours post-dose

  • Peripheral nociceptor activation using Laser Doppler flowmetry

    3.5 hours post-dose

  • +4 more secondary outcomes

Study Arms (3)

V116517

EXPERIMENTAL

V116517 aqueous suspension; 300 mg

Drug: V116517 aqueous suspensionDrug: PlaceboDrug: Capsaicin

Celecoxib

ACTIVE COMPARATOR

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

Drug: Celecoxib capsulesDrug: PlaceboDrug: Capsaicin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: PlaceboDrug: Capsaicin

Interventions

V116517 aqueous suspensionDRUG

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

V116517
Celecoxib capsulesDRUG

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

Also known as: Celebrex®, Celebra®
Celecoxib
PlaceboDRUG

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

CelecoxibPlaceboV116517
CapsaicinDRUG

1% administered topically

CelecoxibPlaceboV116517

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCBR A/S

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

CelecoxibCapsaicin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolyunsaturated AlkamidesAlkenesHydrocarbons, AcyclicCatecholsPhenolsSolanaceous AlkaloidsAlkaloidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 1, 2016

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)