Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Inguinal Hernia Repair

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146198

Enrollment

Registered

2005-09-07

Start date

2005-09-30

Completion date

2006-02-28

Last updated

2006-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative pain, Inguinal Hernia Repair, Capsaicin

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.

Detailed description

Inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the United States. Whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may 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. The purpose of this study is to determine whether a single dose of ALGRX 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.

Interventions

DRUGALGRX 4975

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026