Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
1 other identifier
interventional
428
1 country
4
Brief Summary
The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Shorter than P25 for phase_3
4 active sites
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
December 19, 2013
CompletedFebruary 4, 2014
January 1, 2014
4 months
October 26, 2011
February 20, 2013
January 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
0 - 48 hours
Secondary Outcomes (7)
VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.
0 - 4 hours
VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.
0 - 8 hours
VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.
0 - 24 hours
Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.
0 - 4 hours
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
0 - 8 hours
- +2 more secondary outcomes
Study Arms (4)
Diclofenac Test (lower dose)
EXPERIMENTALDiclofenac Test (upper dose)
EXPERIMENTALCelecoxib
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient is male or female between 18 and 65 years of age
- For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
- Patient must be willing to stay at the study site ≥ 72 hours
You may not qualify if:
- Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
- Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- Patient has used or intends to use any of the medications that are prohibited by the protocol
- Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
- Patient has taken another investigational drug within 30 days prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Premier Research Group Limited
Phoenix, Arizona, 85027, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122, United States
Premier Research Group Limited
Austin, Texas, 78705, United States
Premier Research Group Limited
Salt Lake City, Utah, 84107, United States
Related Publications (1)
Argoff C, McCarberg B, Gudin J, Nalamachu S, Young C. SoluMatrix(R) Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain. Pain Med. 2016 Oct;17(10):1933-1941. doi: 10.1093/pm/pnw012. Epub 2016 Mar 19.
PMID: 26995799DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Solorio
- Organization
- Iroko Pharmaceuticals, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Golf, DPM
Premier Research Group Limited
- PRINCIPAL INVESTIGATOR
Ira Gottlieb, DPM
Chesapeake Research Group, LLC
- PRINCIPAL INVESTIGATOR
Kyle Patrick, DO
Premier Research Group Limited
- PRINCIPAL INVESTIGATOR
S. Thomas Schiffgen, DPM
Premier Research Group Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
October 31, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2012
Study Completion
August 1, 2012
Last Updated
February 4, 2014
Results First Posted
December 19, 2013
Record last verified: 2014-01