Trial Outcomes & Findings for Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery (NCT NCT00366444)

NCT ID: NCT00366444

Last Updated: 2011-04-13

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: 201 participants
• Primary outcome timeframe: Over 48 hours after bunionectomy
• Results posted on: 2011-04-13

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	102	99
Overall Study COMPLETED	101	97
Overall Study NOT COMPLETED	1	2

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 Withdrawal by Subject	1	1
Overall Study Lack of Efficacy	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=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours	Total n=201 Participants Total of all reporting groups
Age Continuous	45 years STANDARD_DEVIATION 11 • n=5 Participants	45 years STANDARD_DEVIATION 12 • n=7 Participants	45 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	86 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	61 participants n=5 Participants	56 participants n=7 Participants	117 participants n=5 Participants
Race/Ethnicity, Customized Black	23 participants n=5 Participants	19 participants n=7 Participants	42 participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 participants n=5 Participants	16 participants n=7 Participants	29 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants	99 participants n=7 Participants	201 participants n=5 Participants
Baseline pain score	6.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	7.3 units on a scale STANDARD_DEVIATION 1.9 • n=7 Participants	7.1 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy	2.5 units on a scale Standard Deviation 2.0	5.6 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 8 hours post single dose

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients With Perceptible Pain Relief on Day 1	84 participants	69 participants

SECONDARY outcome

Timeframe: 8 hours post single dose

Population: 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=84 Participants 25 mg capsule, every 6 hours	Placebo n=69 Participants Oral placebo capsule, every 6 hours
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1	26.0 minutes Interval 18.6 to 31.3	22.2 minutes Interval 16.6 to 35.8

SECONDARY outcome

Timeframe: 8 hours post single dose

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients With Meaningful Pain Relief on Day 1	58 participants	35 participants

SECONDARY outcome

Timeframe: 8 hours post single dose

Population: 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 was not calculable since less than 50% of the patients reported meaningful relief (ie, median cannot be calculated).

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=58 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	70.2 minutes Interval 61.2 to 92.0	—

SECONDARY outcome

Timeframe: 8 hours post single dose

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.

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug	8.2 units on a scale Standard Deviation 9.3	2.6 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 8 hours post single dose

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug	62 participants	40 participants

SECONDARY outcome

Timeframe: 8 hours post single dose

Population: Number of participants analyzed includes only the number of participants with at least a 30% reduction in pain intensity after the 1st dose (see previous outcome measure, #7). Number of placebo patients is intentionally blank as the data (eg., upper CI) was not calculable.

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=62 Participants 25 mg capsule, every 6 hours	Placebo Oral placebo capsule, every 6 hours
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug	60 minutes Interval 45.0 to 90.0	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients Who Required Rescue Medication on Day 1	40 participants	87 participants

SECONDARY outcome

Timeframe: Day 2

Outcome measures

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients Who Required Rescue Medication on Day 2	22 participants	64 participants

SECONDARY outcome

Timeframe: Day 3

Day 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=102 Participants 25 mg capsule, every 6 hours	Placebo n=99 Participants Oral placebo capsule, every 6 hours
Number of Patients Who Required Rescue Medication on Day 3	5 participants	29 participants

Adverse Events

Zipsor (Diclofenac Potassium) Liquid Filled Capsule

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 participants at risk 25 mg capsule, every 6 hours	Placebo n=99 participants at risk Oral placebo capsule, every 6 hours
Skin and subcutaneous tissue disorders Superficial cellulitis of the left knee	0.00% 0/102	1.0% 1/99 • Number of events 1

Other adverse events

Measure	Zipsor (Diclofenac Potassium) Liquid Filled Capsule n=102 participants at risk 25 mg capsule, every 6 hours	Placebo n=99 participants at risk Oral placebo capsule, every 6 hours
Gastrointestinal disorders Abdominal pain	2.9% 3/102	2.0% 2/99
Gastrointestinal disorders Constipation	3.9% 4/102	2.0% 2/99
Gastrointestinal disorders Diarrhea	2.9% 3/102	2.0% 2/99
Gastrointestinal disorders Nausea	7.8% 8/102	18.2% 18/99
Gastrointestinal disorders Vomiting	3.9% 4/102	9.1% 9/99
Investigations Body Temperature Increased	0.00% 0/102	3.0% 3/99
Nervous system disorders Headache	5.9% 6/102	9.1% 9/99
Skin and subcutaneous tissue disorders Pruritus	2.0% 2/102	3.0% 3/99
General disorders Pyrexia	0.00% 0/102	8.1% 8/99
Nervous system disorders Dizziness	0.98% 1/102	4.0% 4/99
Psychiatric disorders Anxiety	0.00% 0/102	3.0% 3/99
Vascular disorders Hypertension	0.00% 0/102	2.0% 2/99

Additional Information

Steve Boesing

Xanodyne Pharmaceuticals, Inc.

Phone: 1-877-926-6396

Email: clinical-trials@xanodyne.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER