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

Information source: Luitpold Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Ketorolac tromethamine (Drug); Ketorolac tromethamine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Luitpold Pharmaceuticals

Official(s) and/or principal investigator(s):
Cyril Clarke, BSc, MB BS, MFPM, Principal Investigator, Affiliation: ICON Developmental Solutions

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.

Clinical Details

Official title: A Phase 1, Double-Blind, Study of the Tolerability of Formulations of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Discomfort Measurement on a Visual Analogue Scale

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

ICON Developmental Solutions, Manchester, United Kingdom
Additional Information

Starting date: December 2006
Last updated: May 27, 2011

Page last updated: August 23, 2015

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