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AzTrials

PainPhase 2NCT00746720

Modulation of the Surgical Inflammatory Response by Etoricoxib

A Phase 2 study testing Etoricoxib 60 mg in people with Pain and Osteoarthritis, Hip, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients and thus reduces pain and suffering. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Pain, Osteoarthritis, Hip, Postoperative Pain
What is being tested?
Etoricoxib 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteGermany
Study dates
May 2006to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

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 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject undergoing elective primary single hip arthroplasty
  • Subject diagnosed with Osteoarthritis / arthrosis
  • Subject has not taken non-steroidal anti-inflammatory drugs within 4 of their terminal half life times prior to enrollment
  • Subject capable of understanding and cooperating with the requirements of the study

Who cannot join

  • Patients with renal insufficiency (serum creatinine >1.5 mg/dl)
  • Recent major trauma or systemic infection (within 3 months)
  • Use of corticosteroid medication or chronic opioids (within 3 months)
  • Any other condition likely to affect prostaglandin and cytokine levels
  • Participation in another clinical study or receipt of an investigational drug within 30 days
  • Hypersensitivity to any component of the etoricoxib and/or placebo tablets
Show all 18Show fewer
  • Uncontrolled hypertension defined as systolic blood pressure >140 mm Hg and diastolic pressure >90 mm Hg at rest after two repeated measurements
  • Congestive heart failure (NYHA II-IV)
  • Cerebrovascular disease
  • Established ischemic heart disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty)
  • Patients with any kind or severity of cirrhosis of the liver or cholestasis or elevated liver function enzymes (ALT or AST 3 fold) as a sign of clinical significant liver malfunction (corresponds to any Child-Pugh-Score ≥5)
  • Patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Pregnancy and lactation
  • Patients with active peptic ulcerations or active gastro-intestinal (GI) bleeding
  • Inflammatory bowel disease
  • Recent history (within the last year) of alcohol or other substance abuse
  • An employee of the sponsor or study site
  • Any neurological syndrome or any other condition leading to contra-indication to spinal anesthesia

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • HELIOS Klinikum Berlin

    Berlin, D-13125

Other trials in Germany

About this study

Official title: Modulation of the Surgical Inflammatory Response by Etoricoxib: Peripheral Versus Central

The purpose of this study is to test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients and thus reduces pain and suffering.

Read the detailed description

This study will be a multiple centre, double-blind, placebo-controlled, randomized, parallel group study conducted in male and female adult patients undergoing elective primary single hip arthroplasty. In part 1 of the study 12 patients will be enrolled in the study and will be administrated 120 mg Etoricoxib or placebo orally on day one post surgery. The results from part 1 should help to adjust sampling time points (for blood, cerebrospinal fluid and hip drain fluid) if necessary. In part 2 of the study 40 patients will be enrolled and should receive 120 mg etoricoxib or placebo two hours before and 24 hours after surgery.

Primary end points will be the inflammatory mediators on peripheral and central levels. After surgical manipulation we expect increased mediators on both sides. It will be investigated if the medication could reduce the mediators compared to placebo and if the effect is related to pharmacokinetic parameters.

Being tested
Etoricoxib 60 mg, Placebo for Etoricoxib 60 mg
Keywords
hip replacement, osteoarthritis, etoricoxib, pain, cerebrospinal fluid, pharmacokinetics
Medical subject headings
Pain, Osteoarthritis, Hip, Pain, Postoperative, Osteoarthritis

What participants receive

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

  • Etoricoxib 60 mgDrug

    Also called Arcoxia 60 mg, MK0663

    film coated tablet 60 mg (orally), 120 mg (= 2 tablets a 60 mg) once daily, on day one post surgery

  • Placebo for Etoricoxib 60 mgDrug

    Also called Matching Placebo

    film coated tablet (orally), two tablets once daily, on day one post surgery

  • Etoricoxib 60 mgDrug

    Also called Arcoxia 60 mg, MK0663

    film coated tablet (orally), 120 mg (= 2 tablets a 60 mg) once daily, two hours before and 24 hours after surgery

  • Placebo for Etoricoxib 60 mgDrug

    Also called Matching Placebo

    film coated tablet (orally), 2 tablets once daily, two hours before and 24 hours after surgery

Study groups in NCT00746720
Study groupRoleWhat they receive
A, 1ExperimentalStudy part 1 (n = 8)
Receives: Drug: Etoricoxib 60 mg
A, 2Placebo comparatorStudy part 1 (n = 4)
Receives: Drug: Placebo for Etoricoxib 60 mg
B, 1ExperimentalStudy part 2 (n = 20)
Receives: Drug: Etoricoxib 60 mg
B, 2Placebo comparatorStudy part 2 (n = 20)
Receives: Drug: Placebo for Etoricoxib 60 mg

What is being measured

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

  1. To test the hypothesis that orally administered etoricoxib (COX-2 inhibitor) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients.

    Measured: within 24 hours post dosing (study part 1) and within 48 hour post dosing (study part 2)

Secondary outcomes (3)

  1. To determine the CSF (cerebrospinal fluid), plasma and tissue pharmacokinetics of orally administered etoricoxib.

    Measured: within 24 hours post dosing (study part 1) and within 48 hours post dosing (study part 2)

  2. To correlate the prostaglandin and cytokine response to clinical outcome parameters after hip arthroplasty.

    Measured: within 4 days post dosing (study part 1 and 2)

  3. To assess the safety (via clinical laboratory tests and adverse events) of a single dose of 120 mg Etoricoxib for one day (Part1) or for two days (Part2) and placebo.

    Measured: within 4 days post dosing (study part 1 and 2)

Timeline

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

  1. First posted4 Sep 2008 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2009
  4. Study completionDec 2010

Why it stopped: Patient recruitment difficulties

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00746720
Sponsor's protocol ID
02B2005
Other IDs
EudraCT No.: 2005-003854-80
Status last verified
Dec 2020
First submitted
3 Sep 2008
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C, Negrescu C, Moric M, Caicedo MS, Tuman KJ. Upregulation of prostaglandin E2 and interleukins in the central nervous system and peripheral tissue during and after surgery in humans. Anesthesiology. 2006 Mar;104(3):403-10. doi: 10.1097/00000542-200603000-00005.

    PubMed 16508385

  • Renner B, Zacher J, Buvanendran A, Walter G, Strauss J, Brune K. Absorption and distribution of etoricoxib in plasma, CSF, and wound tissue in patients following hip surgery--a pilot study. Naunyn Schmiedebergs Arch Pharmacol. 2010 Feb;381(2):127-36. doi: 10.1007/s00210-009-0482-0. Epub 2010 Jan 6.

    PubMed 20052461

  • Renner B, Walter G, Strauss J, Fromm MF, Zacher J, Brune K. Preoperative administration of etoricoxib in patients undergoing hip replacement causes inhibition of inflammatory mediators and pain relief. Eur J Pain. 2012 Jul;16(6):838-48. doi: 10.1002/j.1532-2149.2011.00062.x. Epub 2011 Dec 19.

    PubMed 22337568

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etoricoxib 60 mg in people with Pain and Osteoarthritis, Hip, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

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 4 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: stopped early, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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?

The study was stopped early (reason given: Patient recruitment difficulties). Results are not available in the source record.

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?

To test the hypothesis that orally administered etoricoxib (COX-2 inhibitor) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients. (time frame: within 24 hours post dosing (study part 1) and within 48 hour post dosing (study part 2)). 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 NCT00746720, which also lists 3 linked publications.

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 14 Dec 2020.

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