Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01363063
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Brief Summary:

This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each subject participated in only one part of the study. In Part A subjects received one dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril, in a randomized manner. In Part B subjects were randomized to receive a single intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study, subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a post-study medical was performed prior to discharge.

The objective of this study was to compare the tolerability of formulations of ketorolac tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy volunteers.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Ketorolac tromethamine Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Phase 1, Double-Blind, Study of the Tolerability of Formulations of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Study Start Date : December 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketorolac tromethamine (Part A) Drug: Ketorolac tromethamine
One dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril

Experimental: Ketorolac tromethamine (Part B) Drug: Ketorolac tromethamine
One dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg Ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril




Primary Outcome Measures :
  1. Discomfort Measurement on a Visual Analogue Scale [ Time Frame: 15 minutes post-dose ]
    Following administration of each treatment, subjects completed a visual analogue scale (VAS) (ranging from "no discomfort" to "severe discomfort") at 1, 5, 10 and 15 minutes post-dose. If after the 15 minute VAS assessment discomfort was still present the subject was asked to complete further VAS assessments, at 5 minute intervals, until the discomfort had dissipated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers, aged 18 to 60 years inclusive
  • Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
  • All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilization) throughout the study period
  • Subject had given signed informed consent
  • Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
  • Subject's medical history was considered normal, with no clinically significant abnormalities
  • Subject was considered to be in good health in the opinion of the Investigator, as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
  • Subject's pre-study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
  • Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
  • Body weight of at least 60 kg

Exclusion Criteria:

  • Subject had had a clinically significant illness in the four weeks before screening
  • Use of prescribed medications in the three weeks prior to dosing or over-the-counter preparations for seven days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
  • Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
  • Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
  • Current tobacco use or a history of smoking within the past five years
  • Subject was in the opinion of the Investigator not suitable to participate in the study
  • Subject had participated in any clinical study with an investigational drug/device within three months prior to dosing
  • Subject had a positive result of human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen
  • Subject had had a serious adverse reaction or significant hypersensitivity to any drug
  • Subject had donated 500 mL or more of blood within the three months prior to screening
  • Any history of co-existing nasal polyps, NSAID sensitivity and asthma
  • Allergic reaction to aspirin or other NSAIDs
  • Current upper respiratory tract infection or other respiratory tract condition that could have interfered with the absorption of the nasal spray or with the assessment of adverse events (AEs)
  • Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
  • Use of a monoamine oxidase inhibitor in the 14 days prior to study entry
  • Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
  • Anemia due to unexplained or known gastrointestinal bleeding
  • History of asthma or any other chronic pulmonary disorder
  • Renal impairment or a risk of renal failure due to volume depletion
  • Known sensitivity to lidocaine hydrochloride
  • Previous history of nasal surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363063


Locations
Layout table for location information
United Kingdom
ICON Developmental Solutions
Manchester, United Kingdom
Sponsors and Collaborators
Egalet Ltd
Investigators
Layout table for investigator information
Principal Investigator: Cyril Clarke, BSc, MB BS, MFPM ICON Developmental Solutions

Layout table for additonal information
Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT01363063     History of Changes
Other Study ID Numbers: ROX 2006-01
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac
Ketorolac Tromethamine
Lidocaine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators