Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery

NCT00266786 | Completed Phase 3

• 1 other identifier: ROX 2005-01
• Study Type: interventional
• Target: 321
• Locations: 2 countries
• Sites: 6

Brief Summary

Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The Summed Pain Intensity Difference (SPID) on Day 1

  Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 6 hours.

  6 hours after drug administration

Secondary Outcomes (4)

• Pain intensity difference scores

  Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours

• Quality of analgesia

  Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours

• Global assessment of pain control

  8 hours following first dose of study medication

• Morphine sulfate consumption at 24, 48, and 72 hours

  24, 48, and 72 hours after drug administration

Study Arms (2)

Intranasal Ketorolac Tromethamine

EXPERIMENTAL

Drug: Intranasal Ketorolac Tromethamine

Intranasal Placebo

PLACEBO COMPARATOR

Drug: Intranasal Placebo

Interventions

Intranasal Ketorolac Tromethamine DRUG

Intranasal at 30mg

Intranasal Ketorolac Tromethamine

Intranasal Placebo DRUG

Intranasal Placebo

Intranasal Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women age 18 through 64 years
• Major abdominal surgery
• Body weight ≥ 100 and ≤ 300 pounds
• Negative serum pregnancy test
• Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
• Minimum 48 hour hospital stay and 5 day maximum stay
• Able to provide written informed consent
• Willing and able to comply with all testing requirements of the protocol

You may not qualify if:

• Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
• Allergy or significant reaction to opioids
• Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
• Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
• Use of any intranasal product in past 24 hours
• Clinically significant abnormality on screening lab tests
• History of cocaine use
• Active peptic ulcer disease or significant history of peptic ulcer disease or gastrointestinal bleeding
• Advanced renal impairment or risk for renal failure
• History of other medical problems that could interfere with the study participation
• Pregnancy or breastfeeding
• Participation in another investigational study within past 30 days

Sponsors & Collaborators

• Egalet Ltd: lead

Study Sites (6)

Methodist Hospital

Arcadia, California, 91007, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Clinical Management Services, Inc.

Pasadena, California, 91105, United States

Location

Memorial Hermann Healthcare System

Houston, Texas, 77024, United States

Location

Houston Perinatal Associates

Houston, Texas, 77054, United States

Location

Waikato Clinical Research

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Lincoln Bynum, MD

  ICON Clinical Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 19, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

NZ (1); US (5)