Pain, PostoperativePhase 3NCT00375934
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
A Phase 3 study testing diclofenac potassium (XP21L) in people with Pain, Postoperative, run by Xanodyne Pharmaceuticals at 4 sites in United States.
Trial summary
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- diclofenac potassium (XP21L)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2006to Jan 2007
- 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
- 18-65 years of age
- Have undergone bunionectomy surgery
- Have achieved adequate post-surgical pain
Who cannot join
- Confounding medical conditions which preclude study participation
- Participated in a study of another investigational drug or device within 30 days prior to randomization
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigative Site
Austin, Texas, 78705
Investigative Site
Houston, Texas, 77057
Investigative Site
Salt Lake City, Utah, 84117
Investigative Site
San Marcos, Texas, 78666
About this study
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
- Conditions
- Pain, Postoperative
- Being tested
- diclofenac potassium (XP21L), Placebo
- Keywords
- Bunionectomy, Bunion surgery, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac potassium (XP21L)Drug
Also called Zipsor Liquid Filled Capsule, XP21L
25 mg capsule, every 6 hours
PlaceboDrug
Oral placebo capsule, every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: diclofenac potassium (XP21L) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Measured: Over 48 hours after bunionectomy
Secondary outcomes (10)
Number of Patients With Perceptible Pain Relief on Day 1
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Measured: 8 hours post single dose
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
Measured: 8 hours post single dose
Number of Patients With Meaningful Pain Relief on Day 1
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Measured: 8 hours post single dose
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
Measured: 8 hours post single dose
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.
Measured: 8 hourse post single dose
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Measured: 8 hours post single dose
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Measured: 8 hours post single dose
Number of Patients Who Required Rescue Medication on Day 1
Measured: Day 1
Number of Patients Who Required Rescue Medication on Day 2
Measured: Day 2
Number of Patients Who Required Rescue Medication on Day 3
Day 3 data reflect the use of rescue medication only up to the time of discharge.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2007
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Double blind
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xanodyne Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375934
- Sponsor's protocol ID
- XP21L-302
- Status last verified
- May 2010
- First submitted
- 11 Sep 2006
- Last updated
- 21 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11.
PubMed 22587481Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.
PubMed 20804444
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT00375934
- Acronym / sponsor ID
- XP21L-302
- Conditions
- Pain, Postoperative
- Keywords
- Bunionectomy, Bunion surgery, Post-operative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xanodyne PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Posted 22 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: diclofenac potassium (XP21L) |
| 2 | 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 (3 listed)
- 18-65 years of age
- Have undergone bunionectomy surgery
- Have achieved adequate post-surgical pain
Key exclusion criteria (2 listed)
- Confounding medical conditions which preclude study participation
- Participated in a study of another investigational drug or device within 30 days prior to randomization
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 potassium (XP21L)Also: Zipsor Liquid Filled Capsule, XP21L25 mg capsule, every 6 hours | Drug | 1 |
| PlaceboOral placebo capsule, every 6 hours | Drug | 2 |
Primary outcome
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
Time frame: Over 48 hours after bunionectomy
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
10 secondary outcomes
Number of Patients With Perceptible Pain Relief on Day 1
Time frame: 8 hours post single dose
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
Time frame: 8 hours post single dose
Number of Patients With Meaningful Pain Relief on Day 1
Time frame: 8 hours post single dose
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
Time frame: 8 hours post single dose
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
Time frame: 8 hourse post single dose
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time frame: 8 hours post single dose
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time frame: 8 hours post single dose
Number of Patients Who Required Rescue Medication on Day 1
Time frame: Day 1
Number of Patients Who Required Rescue Medication on Day 2
Time frame: Day 2
Number of Patients Who Required Rescue Medication on Day 3
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22587481Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11.
- Derived from this study: PubMed 20804444Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diclofenac potassium (XP21L) in people with Pain, Postoperative, run by Xanodyne Pharmaceuticals at 4 sites in United States.
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 3 inclusion and 2 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 21 Sep 2010. 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 22 Jun 2010). 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?
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy (time frame: Over 48 hours after bunionectomy). 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 NCT00375934, which also lists 2 linked publications.
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 21 Sep 2010.