NCT05983263

Brief Summary

A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 6, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

March 6, 2023

Last Update Submit

August 1, 2023

Conditions

Coccyx Disorder

Keywords

Chronic CoccygodyniaNeuropathic painCapsaicine 8%

Outcome Measures

Primary Outcomes (1)

  • Responder rate

    Success defined by PGIC ≤ 2.

    3 months after the inclusion visit.

Secondary Outcomes (1)

  • Therapeutic response neuropathic predictive factors

    3 months after the inclusion visit

Interventions

CapsaicinDRUG

Capsaicin 8% patch (QUTENZA) apposed in coccygeal area

Also known as: Capsaicin 8% patch

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical files of 106 patients hospitalized between 2016 and 2022 for persisting coccygodynia (\>3months) and at least one neuropathic symptom in pain expression, and who received capsaicin 8% patch (QUTENZA®) topical treatment.

You may qualify if:

  • Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022

You may not qualify if:

  • Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuralgia

Interventions

CapsaicinTransdermal Patch

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

August 9, 2023

Study Start

August 15, 2023

Primary Completion

December 17, 2023

Study Completion

December 21, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Anonymized dataset. No sharing.