Other Acute Postoperative PainPhase 3NCT01462435

Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

A Phase 3 study testing Diclofenac Test (lower dose), Diclofenac Test (upper dose) and Celecoxib in people with Other Acute Postoperative Pain, run by Iroko Pharmaceuticals, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Other Acute Postoperative Pain
What is being tested?: Diclofenac Test (lower dose), Diclofenac Test (upper dose) and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 428 participants
Where: 4 sitesUnited States
Study dates: Oct 2011to Aug 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Premier Research Group Limited
Austin, Texas, 78705
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
Premier Research Group Limited
Phoenix, Arizona, 85027
Premier Research Group Limited
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: 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

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.

Conditions: Other Acute Postoperative Pain
Being tested: Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac Test (lower dose)Drug
Capsules
Diclofenac Test (upper dose)Drug
Capsules
CelecoxibDrug
200 mg Capsules
PlaceboDrug
Capsules

Study groups in NCT01462435
Study group	Role	What they receive
Diclofenac Test (lower dose)	Experimental	Not described Receives: Drug: Diclofenac Test (lower dose)
Diclofenac Test (upper dose)	Experimental	Not described Receives: Drug: Diclofenac Test (upper dose)
Celecoxib	Active comparator	Not described Receives: Drug: Celecoxib
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 0 - 24 hours
Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Measured: 0 - 4 hours
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Measured: 0 - 8 hours
TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Measured: 0 - 24 hours
TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Measured: 0 - 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Aug 2012

First posted31 Oct 2011 (estimated)
Study startOct 2011
Primary completionFeb 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Other Acute Postoperative PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01462435
Sponsor's protocol ID: DIC3-08-04
Status last verified: Jan 2014
First submitted: 26 Oct 2011
Last updated: 4 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26995799

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01462435
Acronym / sponsor ID: DIC3-08-04
Conditions: Other Acute Postoperative Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Feb 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 31 Oct 2011 (estimated)
Results: Posted 19 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Diclofenac Test (lower dose)	Experimental	Drug: Diclofenac Test (lower dose)
Diclofenac Test (upper dose)	Experimental	Drug: Diclofenac Test (upper dose)
Celecoxib	Active comparator	Drug: Celecoxib
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac Test (lower dose)Capsules	Drug	Diclofenac Test (lower dose)
Diclofenac Test (upper dose)Capsules	Drug	Diclofenac Test (upper dose)
Celecoxib200 mg Capsules	Drug	Celecoxib
PlaceboCapsules	Drug	Placebo

Primary outcome

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.
Time frame: 0 - 48 hours
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.

7 secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 0 - 24 hours
Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.
Time frame: 0 - 4 hours
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
Time frame: 0 - 8 hours
TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
Time frame: 0 - 24 hours
TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
Time frame: 0 - 48 hours

Results and safety

Results posted to the registry on 19 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib	106	105
Diclofenac Test (Lower Dose)	109	109
Diclofenac Test (Upper Dose)	107	106
Placebo	106	101

Primary outcome: 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.

Time frame: 0 - 48 hours. Mean (Standard Deviation). Unit: mm*hour

Measure	Celecoxib n = 106	Diclofenac Test (Lower Dose) n = 109	Diclofenac Test (Upper Dose) n = 107	Placebo n = 106
Value	390.468 (925.1)	392.954 (937.0)	524.315 (1146.1)	76.887 (340.6)

Diclofenac Test (Upper Dose) vs Placebo: Difference in Least Squares Mean: 446.946 (95% CI 206.567 to 687.324), p <0.001, ANCOVA
Diclofenac Test (Lower Dose) vs Placebo: Difference in Least Squares Mean: 316.145 (95% CI 77.136 to 555.155), p = 0.010, ANCOVA
Celecoxib vs Placebo: Difference in Least Squares Mean: 313.119 (95% CI 72.202 to 554.037), p = 0.011, ANCOVA

Population analysed: Intent-to-Treat Population

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	1 of 106 (0.9%)	86 of 106 (81.1%)	Not reported
Diclofenac Test (Lower Dose)	0 of 109 (0%)	84 of 109 (77.1%)	Not reported
Diclofenac Test (Upper Dose)	0 of 107 (0%)	77 of 107 (72%)	Not reported
Placebo	0 of 106 (0%)	63 of 106 (59.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26995799Argoff 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Golf, DPM principal investigator

Premier Research Group Limited

Ira Gottlieb, DPM principal investigator

Chesapeake Research Group, LLC

Kyle Patrick, DO principal investigator

Premier Research Group Limited

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 0 - 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01462435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.