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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01626235
Other study ID # RRR-LUIT-01
Secondary ID
Status Completed
Phase N/A
First received June 20, 2012
Last updated March 11, 2014
Start date July 2012
Est. completion date March 2014

Study information

Verified date March 2014
Source Radnor Registry Research, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.


Description:

Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.


Recruitment information / eligibility

Status Completed
Enrollment 843
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Eligible subjects will meet the following criteria:

1. Eligible diagnoses:

musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea

2. Age GTE 18 years;

3. Decision to discharge from ED to community already made;

4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;

5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;

6. Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.

Exclusion Criteria:

- Eligible subjects will meet none of the following criteria:

1. Patient admitted or placed on observation status from ED;

2. Patient unwilling or unable to comply with telephonic follow-up;

3. Fracture that requires surgical repair (even if at a later date);

4. Patient has diagnosis of any chronic pain syndrome;

5. Patient already routinely takes NSAID or opioid agent;

6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;

7. Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).

Study Design


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Medical University of South Carolina Charleston South Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Cleveland Clinic Cleveland Ohio
United States Ben Taub General Hospital Houston Texas
United States University of Texas HSC at Houston Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States LSU Medical Center New Orleans Louisiana
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Oklahoma HSC Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Radnor Registry Research, Inc Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Outcomes of pain control measures Change in pain score over follow-up interval;
Healthcare resource utilization during follow-up interval;
Patient satisfaction with therapy;
Return to work in employed cohort.
5 days
Secondary Satisfaction and Economic Outcomes Effectiveness of work upon return;
Relative adverse effect profiles of three treatment regimens;
Compliance with therapy;
QOL at conclusion of therapy.
5 days
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