NCT00133133

Brief Summary

Postoperative pain after gall bladder removal can be significant, mobility limiting and extend hospital stay. 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 gall bladder removal.

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 Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 20, 2006

Status Verified

February 1, 2006

First QC Date

August 18, 2005

Last Update Submit

December 18, 2006

Conditions

Postoperative Pain

Keywords

Postoperative painOpen cholecystectomyCapsaicin

Outcome Measures

Primary Outcomes (1)

  • Average numeric rating scale (NRS) scores for pain on ambulation assessed in the evening on the day of surgery and the first four postoperative days

Secondary Outcomes (5)

  • Time to first use and total supplemental pain medication use

  • NRS scores for pain on the first 14 days postoperatively

  • Spirometry on postoperative days 1 to 4

  • Safety and tolerability

  • Pharmacokinetics

Interventions

ALGRX 4975DRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis
  • American Society of Anesthesiologists (ASA) Class I or II

You may not qualify if:

  • Active pancreatitis, any obstruction of the biliary tree, or hyperbilirubinemia (total bilirubin \> 2.5 mg/dL)
  • Previous abdominal surgical procedure with the exception of inguinal hernia repair or appendectomy by the lateral approach or cesarean section or hysterectomy if the surgery was performed more than 1 year prior to study participation and the subject experienced no postoperative complications
  • Diabetes mellitus with HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes mellitus
  • 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)

Emergency Center, Clinical Center of Serbia

Belgrade, 11000, Serbia and Montenegro

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Slobodan Krstic, MD

    Emergency Center, Clinical Center of Serbia

    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

August 18, 2005

First Posted

August 22, 2005

Study Start

July 1, 2005

Study Completion

December 1, 2005

Last Updated

December 20, 2006

Record last verified: 2006-02

Locations

SE(1)