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Completed

NCT Number: NCT00375934

Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age
  • Have undergone bunionectomy surgery
  • Have achieved adequate post-surgical pain

Exclusion criteria

  • Confounding medical conditions which preclude study participation
  • Participated in a study of another investigational drug or device within 30 days prior to randomization

Treatment and study plan

diclofenac potassium (XP21L)

Drug

25 mg capsule, every 6 hours

Other names: Zipsor Liquid Filled Capsule, XP21L

Placebo

Drug

Oral placebo capsule, every 6 hours

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Patients With Perceptible Pain Relief on Day 1

    Time frame: 8 hours post single dose

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

  2. Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1

    Time frame: 8 hours post single dose

  3. Number of Patients With Meaningful Pain Relief on Day 1

    Time frame: 8 hours post single dose

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

  4. Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1

    Time frame: 8 hours post single dose

  5. Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug

    Time frame: 8 hourse 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.

  6. Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

    Time frame: 8 hours post single dose

  7. Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

    Time frame: 8 hours post single dose

  8. Number of Patients Who Required Rescue Medication on Day 1

    Time frame: Day 1

  9. Number of Patients Who Required Rescue Medication on Day 2

    Time frame: Day 2

  10. Number of Patients Who Required Rescue Medication on Day 3

    Time frame: Day 3

    Day 3 data reflect the use of rescue medication only up to the time of discharge.

Sponsors and collaborators

Lead sponsor

Xanodyne Pharmaceuticals

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
First posted
Sep 13, 2006
Registry last updated
Sep 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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