NCT00146198

Brief Summary

Hernia repair is one of the most common operations. Whilst there are few complications, pain may last for several weeks and extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_2 postoperative-pain

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2 postoperative-pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 20, 2006

Status Verified

December 1, 2006

First QC Date

September 4, 2005

Last Update Submit

December 18, 2006

Conditions

Postoperative Pain

Keywords

Postoperative painInguinal Hernia RepairCapsaicin

Outcome Measures

Primary Outcomes (1)

  • The average daily VAS pain scores, assessed on a 100 mm VAS during movement upon arising in the morning and retiring in the evening, during the first week after surgery.

Secondary Outcomes (3)

  • Time to supplemental medication usage

  • Average daily VAS pain scores, assessed during movement upon arising in the morning and retiring in the evening, during the first 4 weeks after surgery

  • Safety and tolerability

Interventions

ALGRX 4975DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.

You may not qualify if:

  • The subject has undergone a lower abdomen surgical procedure in the past.
  • The subject is currently scheduled to undergo bilateral inguinal hernia repair.
  • Personal or familial contraindications in undergoing general anesthesia.
  • Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dagkirurgisk Klinik

Hørsholm, DK-2970, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Henrik Kehlet, MD PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2005

First Posted

September 7, 2005

Study Start

September 1, 2005

Study Completion

February 1, 2006

Last Updated

December 20, 2006

Record last verified: 2006-12

Locations

DK(1)