CompletedNCT00601458Updated Apr 10, 2015Results posted

Bunionectomy Study (0000-063)

A Phase 1 interventional study of pregabalin and naproxen sodium in Acute Pain, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-10.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.

Conditions studied

Acute Pain

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Acute Pain 876

Keywords

Primary, unilateral, first metatarsal bunionectomy with osteotomy

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 100 is above the median of 90 across 732 interventional studies indexed under Acute Pain.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient is a man or woman between 18 and 65 years of age
For Women of Child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit
Patient is scheduled to have a bunionectomy
Patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up
Patient is capable of operating a Patient Controlled Analgesia device

Exclusion criteria

Exclusion Criteria:

Patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery
Patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs
Patient has an estimated creatinine clearance of \< or = 60 mL per min
Patient has a history of drug abuse or dependence, or patient has a positive urine drug screen
Patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 100 participants (actual)

Study arms

Active comparator
Arm 1: Pregabalin 300 mg
Drug: pregabalin
Active comparator
Arm 2: naproxen sodium 550 mg
Drug: naproxen sodium
Placebo comparator
Arm 3: Placebo
Drug: Comparator: Placebo

Interventions

Drugpregabalin
Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Drugnaproxen sodium
Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.
Also known as: naproxen
DrugComparator: Placebo
Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

What researchers measure

Primary outcomes

Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery
Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Time frame: First 24 hours following surgery

Secondary outcomes

Time to First Request of PCA Hydromorphone
Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.
Time frame: First 24 hours following surgery

Results

Posted Apr 8, 2010

Participant flow

First Patient Entered: 25 July 2007 Last Patient Last Visit: 28 January 2008 1 site

Participant flow — Overall Study
Milestone	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo
Started	36	34	30
Completed	32	29	28
Not completed	4	5	2
Withdrew: Dosing error	1	0	0
Withdrew: Incomplete data	0	2	0
Withdrew: Protocol violation	3	2	1
Withdrew: Early termination	0	1	1

Outcome measures

PrimaryTotal Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery

Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.

Time frame:: First 24 hours following surgery
Reported as:: Geometric mean · milligrams

Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery
milligrams	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo
Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery	2.94 (2.00 to 5.35)	2.07 (0.80 to 4.60)	5.96 (4.50 to 7.70)

Statistical analysis

Pregabalin 300 mg vs Placebo · ANOVA · p = 0.005 (1-sided alpha = 0.045 Hochberg closed testing procedure) · Mean difference (final values): -50.7 · 97.8% CI -73.6 to -8.0The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.
Naproxen Sodium 550 mg vs Placebo · ANOVA · p = 0.0001 (1-sided alpha = 0.045 Hochberg closed testing procedure) · Mean difference (final values): -65.4 · 97.8% CI -81.7 to -34.6The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.

SecondaryTime to First Request of PCA Hydromorphone

Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.

Time frame:: First 24 hours following surgery
Reported as:: Median · Hours

Time to First Request of PCA Hydromorphone
Hours	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo
Time to First Request of PCA Hydromorphone	7.3 (5.8 to 9.4)	9.1 (7.1 to 13.6)	5.8 (5.1 to 7.4)

Statistical analysis

Pregabalin 300 mg vs Placebo · Log Rank · p = 0.004 (1-sided alpha = 0.045 Hochberg closed testing procedure) · Median difference (final values): 1.46 · 95% CI 0.183 to 2.95Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians
Naproxen Sodium 550 mg vs Placebo · Log Rank · p = <0.001 (1-sided alpha = 0.045 Hochberg closed testing procedure) · Median difference (final values): 3.70 · 95% CI 1.77 to 6.72Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians

Adverse events

Collected over AEs were collected from the time the subject signed consent until 14 days following the last dose of study mediciation.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pregabalin 300 mg	—	0/36 (0%)	26/36 (72.2%)
Naproxen Sodium 550 mg	—	0/34 (0%)	19/34 (55.9%)
Placebo	—	0/30 (0%)	25/30 (83.3%)

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo
NauseaGastrointestinal disorders	16/36	14/34	21/30
VomitingGastrointestinal disorders	7/36	9/34	18/30
HeadacheNervous system disorders	8/36	1/34	4/30
DizzinessNervous system disorders	6/36	5/34	3/30
PruritusSkin and subcutaneous tissue disorders	1/36	5/34	5/30
HyperhidrosisSkin and subcutaneous tissue disorders	0/36	1/34	4/30
Oxygen Saturation DecreasedInvestigations	2/36	0/34	3/30
Pharyngolaryngeal PainRespiratory, thoracic and mediastinal disorders	0/36	0/34	2/30
ConstipationGastrointestinal disorders	2/36	2/34	1/30
PainGeneral disorders	0/36	2/34	0/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Mean	40.3 ± 14.1	40.6 ± 13.5	38.8 ± 11.6	39.9 ± 13.1

Sex: Female, Male
Sex: Female, Male(Participants)	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Female	27	23	23	73
Male	5	6	5	16

Body Weight
Body Weight(Kilograms)	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Mean	72.3 ± 18.1	76.7 ± 17.2	77.2 ± 16.9	75.3 ± 17.4

Lidocaine Use
Lidocaine Use(Milliliters)	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Mean	15.0 ± 2.3	15.9 ± 2.7	14.6 ± 1.6	15.2 ± 2.2

Propofol Use
Propofol Use(Milligrams)	Pregabalin 300 mg	Naproxen Sodium 550 mg	Placebo	Total
Mean	348.4 ± 132.9	364.5 ± 122.8	353.9 ± 105.8	355.4 ± 121.1

Study locations

No study locations are listed for this record.

References and documents

Publications

Wang H, Gargano C, Lukac S, Jackson A, Beals C, Smiley P, Drexel M, Ruddy M, Herman G, Johnson-Levonas AO, Medve R, Webster L, Reicin A. An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics. Adv Ther. 2010 Dec;27(12):963-80. doi: 10.1007/s12325-010-0084-8. Epub 2010 Nov 3. PubMed 21052881 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00601458
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Jan 28, 2008
Start date: Jul 2007
Primary completion: Jan 2008
Completion: Jan 2008
Results posted: Apr 8, 2010
Last update: Apr 10, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

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