Trial Outcomes & Findings for Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery (NCT NCT00375934)
NCT ID: NCT00375934
Last Updated: 2010-09-21
Results Overview
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Over 48 hours after bunionectomy
Results posted on
2010-09-21
Participant Flow
Participant milestones
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
25 mg capsule, every 6 hours
|
Placebo
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
96
|
95
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
25 mg capsule, every 6 hours
|
Placebo
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Baseline characteristics by cohort
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
41 years
STANDARD_DEVIATION 13 • n=93 Participants
|
40 years
STANDARD_DEVIATION 12 • n=4 Participants
|
40 years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
172 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
66 participants
n=93 Participants
|
57 participants
n=4 Participants
|
123 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=93 Participants
|
15 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 participants
n=93 Participants
|
26 participants
n=4 Participants
|
47 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=93 Participants
|
101 participants
n=4 Participants
|
200 participants
n=27 Participants
|
|
Baseline Pain Score
|
7.5 units on a scale
STANDARD_DEVIATION 1.6 • n=93 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: Over 48 hours after bunionectomyPain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
|
3.3 units on a scale
Standard Deviation 2.2
|
5.7 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 8 hours post single doseTimes to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients With Perceptible Pain Relief on Day 1
|
72 participants
|
63 participants
|
SECONDARY outcome
Timeframe: 8 hours post single dosePopulation: Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=72 Participants
25 mg capsule, every 6 hours
|
Placebo
n=63 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
|
42.9 minutes
Interval 33.6 to 53.3
|
36.0 minutes
Interval 29.8 to 60.4
|
SECONDARY outcome
Timeframe: 8 hours post single doseTimes to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients With Meaningful Pain Relief on Day 1
|
50 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 8 hours post single dosePopulation: Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4). Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results).
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=50 Participants
25 mg capsule, every 6 hours
|
Placebo
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
|
90.6 minutes
Interval 85.0 to 119.7
|
—
|
SECONDARY outcome
Timeframe: 8 hourse post single dosePain 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.
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
|
5.9 units on a scale
Standard Deviation 7.4
|
1.9 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 8 hours post single doseOutcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
|
51 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 8 hours post single dosePopulation: Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=51 Participants
25 mg capsule, every 6 hours
|
Placebo
n=31 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
|
110 minutes
Interval 90.0 to 147.0
|
300 minutes
Interval 120.0 to 300.0
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients Who Required Rescue Medication on Day 1
|
53 participants
|
93 participants
|
SECONDARY outcome
Timeframe: Day 2Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients Who Required Rescue Medication on Day 2
|
30 participants
|
68 participants
|
SECONDARY outcome
Timeframe: Day 3Day 3 data reflect the use of rescue medication only up to the time of discharge.
Outcome measures
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 Participants
25 mg capsule, every 6 hours
|
Placebo
n=101 Participants
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Number of Patients Who Required Rescue Medication on Day 3
|
4 participants
|
19 participants
|
Adverse Events
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 participants at risk
25 mg capsule, every 6 hours
|
Placebo
n=101 participants at risk
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/99
|
0.99%
1/101
|
Other adverse events
| Measure |
Zipsor (Diclofenac Potassium) Liquid Filled Capsule
n=99 participants at risk
25 mg capsule, every 6 hours
|
Placebo
n=101 participants at risk
Oral placebo capsule, every 6 hours
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.0%
2/99
|
0.00%
0/101
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
6/99
|
0.99%
1/101
|
|
Gastrointestinal disorders
Constipation
|
4.0%
4/99
|
5.0%
5/101
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/99
|
3.0%
3/101
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
2/99
|
2.0%
2/101
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/99
|
2.0%
2/101
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/99
|
2.0%
2/101
|
|
Gastrointestinal disorders
Nausea
|
18.2%
18/99
|
26.7%
27/101
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
8/99
|
7.9%
8/101
|
|
General disorders
Feeling Hot
|
0.00%
0/99
|
3.0%
3/101
|
|
General disorders
Injection site pain
|
0.00%
0/99
|
3.0%
3/101
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
2/99
|
0.00%
0/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/99
|
2.0%
2/101
|
|
Nervous system disorders
Dizziness
|
6.1%
6/99
|
7.9%
8/101
|
|
Nervous system disorders
Headache
|
7.1%
7/99
|
6.9%
7/101
|
|
Nervous system disorders
Somnolence
|
6.1%
6/99
|
5.0%
5/101
|
|
Psychiatric disorders
Nightmare
|
2.0%
2/99
|
0.00%
0/101
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.0%
1/99
|
3.0%
3/101
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/99
|
2.0%
2/101
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/99
|
2.0%
2/101
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/99
|
2.0%
2/101
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER