Osteoarthritis PainPhase 1/2NCT01980940

The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168)

A Phase 1/2 study testing Etoricoxib 75 mg 4% DMSO Gel, Etoricoxib 75 mg 4% PG Gel and Etoricoxib 150 mg 4% DMSO Gel in people with Osteoarthritis Pain, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis Pain
What is being tested?: Etoricoxib 75 mg 4% DMSO Gel, Etoricoxib 75 mg 4% PG Gel and Etoricoxib 150 mg 4% DMSO Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: No sites listed yet
Study dates: 23 Dec 2013to 26 Nov 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for >6 months based on clinical and radiographic criteria;
Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or III;
The knee designated as the "study joint" must be the participant's primary source of pain/disability in the lower extremity. If both knees are affected, the most painful joint will be selected for evaluation for inclusion and clinical response;
Female participants of childbearing potential must demonstrate a serum beta human chorionic gonadotropin (β-hCG) level consistent with a non-gravid state at the screening visit and urine β-hCG at Day -1 prior to first dosing and agree to use adequate oral or barrier contraception or abstain from sexual contact at least 7 days prior to treatment and continuing through the treatment period or a discontinuation visit;
Willing to limit alcohol intake (beer 8 ounces, wine 4 ounces, liquor 1 ounce) to no more than 14 drinks a week (no more than 2 in a day) and to avoid unaccustomed strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical therapy) for the duration of the study;
Judged to be in general good health with the exception of osteoarthritis based on medical history, physical examination, and routine laboratory tests.
For Part 2, if the participant is a regular user of non-steroidal anti-inflammatory drugs (NSAIDs) including coxibs he/she must report a history of positive therapeutic benefit in osteoarthritis of the knee with NSAID/coxibs in the past;
For Part 2, participants must be taking a single NSAID on a regular basis and at a prescription strength for at least 30 days prior to study screening ("regular basis" is defined as at least 25 of the previous 30 days) for treatment of symptoms of osteoarthritis.

Who cannot join

Has a concurrent medical/arthritic disease;
History of acute ligamentous or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected knee within 6 months prior to study entry;
Is a candidate for imminent joint replacement;
Has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (apart from migraine), or other systemic disease that in the opinion of the investigator contraindicates the use of etoricoxib;
Has congestive heart failure with symptoms that occur at rest or minimal activity;
Has unstable angina that occurs at rest or with minimal activity;

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Has uncontrolled hypertension (sitting diastolic blood pressure >95 mm Hg, or sitting systolic blood pressure >165 mm Hg);
Has a history of stroke or transient ischemic attack (TIA) within the previous 6 months;
Has a history of hepatitis/hepatic disease that has been active within the previous 2 years;
Has a history of neoplastic disease;
Is currently a user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years;
Is allergic of has hypersensitivity to aspirin, ibuprofen, rofecoxib, celecoxib, valdecoxib, other NSAIDs, acetaminophen, or sulfa drugs;
Has used intravenous, intramuscular, or oral corticosteroids within 1 month of study entry;
Has used glucosamine and/or chondroitin sulfate for <6 months prior to study start;
Has used intra-articular steroids, HYALGAN™ (sodium hyaluronate, Sanofi Pharmaceuticals), or SYNVISC™ (hylan G-F 20, Wyeth-Ayerst Pharmaceuticals) to the study joint within 3 months of entry into the study or intra-articular steroids, HYALGAN™, or SYNVISC™ to any other joint within 1 month of study entry;
Has used topical, oral or systemic analgesic medications within 2 weeks of study entry and for the duration of the study;
Requires treatment with warfarin, heparin, high-dose aspirin (>325 mg), or digoxin;
Has used Arcoxia® within 2 weeks of study entry.

About this study

Official title: A Study to Assess the Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Osteoarthritis Patients

Study Part 1 is designed to assess the plasma pharmacokinetics of etoricoxib (ETOR) 4% dimethyl sulfoxide (DMSO) and propylene glycol (PG) formulations, each at 2 different doses, upon single-dose topical administration on the knee of osteoarthritis participants. Study Part 2 is designed to evaluate the efficacy of topical etoricoxib vs. placebo in the treatment of osteoarthritis of the knee. The primary hypothesis is that topical etoricoxib will be more effective than placebo in the treatment of osteoarthritis of the knee over 2 weeks of treatment as assessed by time-weighted average change from baseline on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analogue (VA) 3.0 pain subscale.

Read the detailed description

Part I of the study will consist of a single-dose, open-label, randomized, four-way cross over study with topical administration of etoricoxib gel on the knee of osteoarthritis participants. The washout between successive dose administrations will be at least one week. Part 2 of the study will consist of double-blind, randomized, placebo-controlled, parallel groups, multiple dose, twice daily topical administration of etoricoxib or placebo gel on the knee of osteoarthritis participants for a period of two weeks.

Conditions: Osteoarthritis Pain
Being tested: Etoricoxib 75 mg 4% DMSO Gel, Etoricoxib 75 mg 4% PG Gel, Etoricoxib 150 mg 4% DMSO Gel, Etoricoxib 150 mg 4% PG Gel, Etoricoxib 163 mg 4% DMSO gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Etoricoxib 75 mg 4% DMSO GelDrug
Etoricoxib 75 mg 4% DMSO gel applied topically.
Etoricoxib 75 mg 4% PG GelDrug
Etoricoxib 75 4% PG gel applied topically.
Etoricoxib 150 mg 4% DMSO GelDrug
Etoricoxib 150 mg 4% DMSO gel applied topically.
Etoricoxib 150 mg 4% PG GelDrug
Etoricoxib 150 mg 4% PG gel applied topically.
Etoricoxib 163 mg 4% DMSO gelDrug
Etoricoxib 163 mg 4% DMSO gel applied topically
PlaceboDrug
Placebo gel applied topically.
Etoricoxib 50 mg 4% DMSODrug
Etoricoxib 50 mg 4% DMSO gel applied topically.
Matching Placebo to Etoricoxib 50 mg 4% DMSO GelDrug
Matching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically.

Study groups in NCT01980940
Study group	Role	What they receive
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO	Experimental	Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically. Receives: Drug: Etoricoxib 75 mg 4% DMSO Gel; Drug: Etoricoxib 75 mg 4% PG Gel; Drug: Etoricoxib 150 mg 4% DMSO Gel; Drug: Etoricoxib 150 mg 4% PG Gel
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG	Experimental	Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically. Receives: Drug: Etoricoxib 75 mg 4% DMSO Gel; Drug: Etoricoxib 75 mg 4% PG Gel; Drug: Etoricoxib 150 mg 4% DMSO Gel; Drug: Etoricoxib 150 mg 4% PG Gel
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO	Experimental	Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically. Receives: Drug: Etoricoxib 75 mg 4% DMSO Gel; Drug: Etoricoxib 75 mg 4% PG Gel; Drug: Etoricoxib 150 mg 4% DMSO Gel; Drug: Etoricoxib 150 mg 4% PG Gel
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO	Experimental	Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically. Receives: Drug: Etoricoxib 75 mg 4% DMSO Gel; Drug: Etoricoxib 75 mg 4% PG Gel; Drug: Etoricoxib 150 mg 4% DMSO Gel; Drug: Etoricoxib 150 mg 4% PG Gel
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG	Experimental	Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose [OD]), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically. Receives: Drug: Etoricoxib 75 mg 4% DMSO Gel; Drug: Etoricoxib 75 mg 4% PG Gel; Drug: Etoricoxib 150 mg 4% DMSO Gel; Drug: Etoricoxib 163 mg 4% DMSO gel
Pt 1: Placebo (Deviation)	Other	Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only. Receives: Drug: Placebo
Pt 2: ETOR 50 DMSO	Experimental	Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks. Receives: Drug: Etoricoxib 50 mg 4% DMSO
Pt 2: Placebo	Placebo comparator	Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks. Receives: Drug: Matching Placebo to Etoricoxib 50 mg 4% DMSO Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing
Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).
Measured: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing
Tmax determined for the period up to 72 hours post-single application.
Measured: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing
Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).
Measured: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.
Measured: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14

Secondary outcomes (5)

Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.
Measured: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.
Measured: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').
Measured: Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)
Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Measured: Study Part 1: up to Day 47; Study Part 2: up to Day 28
Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Measured: Study Part 1: up to Day 47; Study Part 2: up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 201326 Nov 2014

First posted11 Nov 2013 (estimated)
Study start23 Dec 2013
Primary completion26 Nov 2014
Study completion26 Nov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01980940
Sponsor's protocol ID: 0663-168
Status last verified: Feb 2022
First submitted: 5 Nov 2013
Last updated: 27 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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BioPoly® Partial Resurfacing Knee Implant IDE
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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RecruitingPhase 2
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Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis

All Osteoarthritis Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Osteoarthritis Patients
ClinicalTrials.gov ID: NCT01980940
Acronym / sponsor ID: 0663-168
Conditions: Osteoarthritis Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 23 Dec 2013 (actual)
Primary completion: 26 Nov 2014 (actual)
Study completion: 26 Nov 2014 (actual)
First posted: 11 Nov 2013 (estimated)
Results: Posted 11 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO	Experimental	Drug: Etoricoxib 75 mg 4% DMSO Gel, Drug: Etoricoxib 75 mg 4% PG Gel, Drug: Etoricoxib 150 mg 4% DMSO Gel, Drug: Etoricoxib 150 mg 4% PG GelSingle-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG	Experimental	Drug: Etoricoxib 75 mg 4% DMSO Gel, Drug: Etoricoxib 75 mg 4% PG Gel, Drug: Etoricoxib 150 mg 4% DMSO Gel, Drug: Etoricoxib 150 mg 4% PG GelSingle-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO	Experimental	Drug: Etoricoxib 75 mg 4% DMSO Gel, Drug: Etoricoxib 75 mg 4% PG Gel, Drug: Etoricoxib 150 mg 4% DMSO Gel, Drug: Etoricoxib 150 mg 4% PG GelSingle-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO	Experimental	Drug: Etoricoxib 75 mg 4% DMSO Gel, Drug: Etoricoxib 75 mg 4% PG Gel, Drug: Etoricoxib 150 mg 4% DMSO Gel, Drug: Etoricoxib 150 mg 4% PG GelSingle-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG	Experimental	Drug: Etoricoxib 75 mg 4% DMSO Gel, Drug: Etoricoxib 75 mg 4% PG Gel, Drug: Etoricoxib 150 mg 4% DMSO Gel, Drug: Etoricoxib 163 mg 4% DMSO gelSingle-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose [OD]), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
Pt 1: Placebo (Deviation)	Other	Drug: PlaceboParticipants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
Pt 2: ETOR 50 DMSO	Experimental	Drug: Etoricoxib 50 mg 4% DMSOEtoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
Pt 2: Placebo	Placebo comparator	Drug: Matching Placebo to Etoricoxib 50 mg 4% DMSO GelMatching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for >6 months based on clinical and radiographic criteria;
Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or III;
The knee designated as the "study joint" must be the participant's primary source of pain/disability in the lower extremity. If both knees are affected, the most painful joint will be selected for evaluation for inclusion and clinical response;
Female participants of childbearing potential must demonstrate a serum beta human chorionic gonadotropin (β-hCG) level consistent with a non-gravid state at the screening visit and urine β-hCG at Day -1 prior to first dosing and agree to use adequate oral or barrier contraception or abstain from sexual contact at least 7 days prior to treatment and continuing through the treatment period or a discontinuation visit;
Willing to limit alcohol intake (beer 8 ounces, wine 4 ounces, liquor 1 ounce) to no more than 14 drinks a week (no more than 2 in a day) and to avoid unaccustomed strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical therapy) for the duration of the study;

Key exclusion criteria (18 listed)

Has a concurrent medical/arthritic disease;
History of acute ligamentous or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected knee within 6 months prior to study entry;
Is a candidate for imminent joint replacement;
Has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (apart from migraine), or other systemic disease that in the opinion of the investigator contraindicates the use of etoricoxib;
Has congestive heart failure with symptoms that occur at rest or minimal activity;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Etoricoxib 75 mg 4% DMSO GelEtoricoxib 75 mg 4% DMSO gel applied topically.	Drug	Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO, Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO, Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO, Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG, Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
Etoricoxib 75 mg 4% PG GelEtoricoxib 75 4% PG gel applied topically.	Drug	Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO, Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO, Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO, Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG, Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
Etoricoxib 150 mg 4% DMSO GelEtoricoxib 150 mg 4% DMSO gel applied topically.	Drug	Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO, Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO, Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO, Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG, Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
Etoricoxib 150 mg 4% PG GelEtoricoxib 150 mg 4% PG gel applied topically.	Drug	Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO, Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO, Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO, Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG
Etoricoxib 163 mg 4% DMSO gelEtoricoxib 163 mg 4% DMSO gel applied topically	Drug	Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG
PlaceboPlacebo gel applied topically.	Drug	Pt 1: Placebo (Deviation)
Etoricoxib 50 mg 4% DMSOEtoricoxib 50 mg 4% DMSO gel applied topically.	Drug	Pt 2: ETOR 50 DMSO
Matching Placebo to Etoricoxib 50 mg 4% DMSO GelMatching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically.	Drug	Pt 2: Placebo

Primary outcome

Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing
Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).
Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing
Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Tmax determined for the period up to 72 hours post-single application.
Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing
Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application
Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).
Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale
Time frame: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14
The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.

5 secondary outcomes

Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale
Time frame: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14
Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale
Time frame: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14
Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)
Time frame: Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)
Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event
Time frame: Study Part 1: up to Day 47; Study Part 2: up to Day 28
Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Study Part 1: up to Day 47; Study Part 2: up to Day 28

Results and safety

Results posted to the registry on 11 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO	5	5
Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG	5	5
Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO	5	5
Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO	3	3
Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG	2	2
Pt 1: Placebo (Deviation)	2	0
Pt 2: ETOR 50 DMSO	24	24
Pt 2: Placebo	24	24

Primary outcome: Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing

Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application. Least squares mean (90% Confidence Interval). Unit: mg

Measure	ETOR 75 DMSO n = 20	ETOR 75 PG n = 20	ETOR 150 DMSO n = 20	ETOR 150 PG n = 18	ETOR OD n = 0	Placebo (Pt 1) (Deviation) n = 0
Value	12.39 (8.24)	2.43 (2.14)	27.30 (15.30)	3.74 (3.79)	–	–

ETOR 75 DMSO vs ETOR 75 PG: Treatment ratio: 5.09 (90% CI 4.03 to 6.42), ANOVA
ETOR 150 DMSO vs ETOR 150 PG: Treatment ratio: 7.30 (90% CI 6.05 to 8.81), ANOVA
ETOR 75 DMSO vs ETOR 150 DMSO: Treatment ratio: 0.45 (90% CI 0.38 to 0.55), ANOVA

Population analysed: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation

Primary outcome: Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing

Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application. Median (Full Range). Unit: hour

Measure	ETOR 75 DMSO n = 20	ETOR 75 PG n = 18	ETOR 150 DMSO n = 20	ETOR 150 PG n = 18	ETOR OD n = 2	Placebo (Pt 1) (Deviation) n = 0
Value	30.0 (23.5 to 72.0)	48.0 (1.0 to 72.0)	24.0 (2.0 to 72.0)	48 (24.0 to 72.0)	36.0 (24.0 to 48.0)	–

Population analysed: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation

Primary outcome: Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing

Time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application. Least squares mean (90% Confidence Interval). Unit: mg

Measure	ETOR 75 DMSO n = 20	ETOR 75 PG n = 20	ETOR 150 DMSO n = 20	ETOR 150 PG n = 18	ETOR OD n = 0	Placebo (Pt 1) (Deviation) n = 0
Value	611.3 (400.97)	65.6 (112.83)	1309.7 (686.34)	161.3 (172.96)	–	–

ETOR 75 DMSO vs ETOR 75 PG: Treatment ratio: 9.32 (90% CI 4.77 to 18.18), ANOVA
ETOR 150 DMSO vs ETOR 150 PG: Treatment ratio: 8.12 (90% CI 6.39 to 10.32), ANOVA
ETOR 75 DMSO vs ETOR 150 DMSO: Treatment ratio: 0.47 (90% CI 0.39 to 0.57), ANOVA

Population analysed: PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation

Primary outcome: Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale

Time frame: Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14. Mean (Standard Deviation). Unit: Units on a scale

Measure	ETOR 50 DMSO n = 24	Placebo (Pt 2) n = 24
BL to Day 2	-24.21 (76.88)	-37.21 (101.77)
BL to Day 4	-34.29 (69.15)	-43.92 (94.81)
BL to Day 7	-45.81 (67.92)	-54.11 (94.11)
BL to Day 11	-59.42 (71.12)	-63.60 (90.99)
BL to Day 14	-69.60 (75.81)	-72.60 (91.35)

ETOR 50 DMSO vs Placebo (Pt 2): Mean Difference (Final Values): -27.3 (90% CI -63.6 to 8.9), p = 0.2113, constrained longitudinal data analysis
ETOR 50 DMSO vs Placebo (Pt 2): Mean Difference (Final Values): -22.7 (90% CI -55.7 to 10.3), p = 0.2548, constrained longitudinal data analysis
ETOR 50 DMSO vs Placebo (Pt 2): Mean Difference (Final Values): -21.4 (90% CI -54.9 to 12.0), p = 0.2880, constrained longitudinal data analysis

Population analysed: Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study Part 1: up to Day 47; Study Part 2: up to Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ETOR 75 DMSO (Pt 1)	0 of 20 (0%)	0 of 20 (0%)	Not reported
ETOR 75 PG (Pt 1)	0 of 20 (0%)	0 of 20 (0%)	Not reported
ETOR 150 DMSO (Pt 1)	0 of 20 (0%)	0 of 20 (0%)	Not reported
ETOR 150 PG (Pt 1)	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
ETOR OD (Pt 1)	0 of 2 (0%)	2 of 2 (100%)	Not reported
Placebo (Pt 1) (Deviation)	0 of 2 (0%)	0 of 2 (0%)	Not reported
ETOR 50 DMSO (Pt 2)	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
Placebo (Pt 2)	0 of 24 (0%)	2 of 24 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Etoricoxib 75 mg 4% DMSO Gel, Etoricoxib 75 mg 4% PG Gel and Etoricoxib 150 mg 4% DMSO Gel in people with Osteoarthritis Pain, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing (time frame: Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01980940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.