Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder
12. januar 2018 oppdatert av: MEDRx USA, Inc.
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of Shoulder
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
210
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35216
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Arizona
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Scottsdale, Arizona, Forente stater, 85258
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California
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Los Angeles, California, Forente stater, 90036
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San Diego, California, Forente stater, 92120
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Colorado
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Denver, Colorado, Forente stater, 80239
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Florida
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Clearwater, Florida, Forente stater, 33761
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Coral Gables, Florida, Forente stater, 33134
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Fort Lauderdale, Florida, Forente stater, 33136
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Kissimmee, Florida, Forente stater, 34741
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Lauderdale Lakes, Florida, Forente stater, 33319
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Miami, Florida, Forente stater, 33155
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Orlando, Florida, Forente stater, 32804
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Idaho
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Boise, Idaho, Forente stater, 83702
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Kentucky
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Lexington, Kentucky, Forente stater, 40504
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
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Michigan
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Southfield, Michigan, Forente stater, 48034
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North Carolina
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Raleigh, North Carolina, Forente stater, 27612
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North Dakota
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Fargo, North Dakota, Forente stater, 58103
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Ohio
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Zanesville, Ohio, Forente stater, 43701
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Oregon
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Gresham, Oregon, Forente stater, 97030
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Pennsylvania
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Altoona, Pennsylvania, Forente stater, 16602
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South Carolina
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Charleston, South Carolina, Forente stater, 29412
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Texas
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Dallas, Texas, Forente stater, 75254
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El Paso, Texas, Forente stater, 79902
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San Antonio, Texas, Forente stater, 78229
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San Antonio, Texas, Forente stater, 78207
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Temple, Texas, Forente stater, 76502
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control.
- Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24 hours and ≤ 7 days preceding the screening visit.
- Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a Numeric Pain Rating Scale (NPRS).
Exclusion Criteria:
- Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or bursitis of the shoulders, bicipital tendonitis; or orthopedic surgical treatment is required.
- Subject has a positive Drop Arm Test indicative of a suspected tear; a positive O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability; a positive Yergason's Test which would be indicative of bicipital tendonitis.
- Subject had a previous episode of shoulder pain in the same area within two weeks prior to the current episode; history of chronic pain in the target shoulder; history of rotator cuff injury or previous surgery in the same area.
- Subject received passive physical therapy treatments for the pain in the target shoulder within the past 24 hours.
- Subject has used oral pharmacologic treatment less than 5 half-lives before the baseline assessments.
- Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment.
- Subject has received systemic corticosteroids in the 30 days preceding the screening visit; or local injections such as intra-articular, bursal, peritendinous; topical corticosteroids are acceptable unless applied to the target joint; and inhaled or intranasal steroids acceptable (e.g., Flonase®).
- Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days).
- Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days.
- Subject has a history or physical assessment finding of clinically significant GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician.
- Subject has fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis such as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis is acceptable as long as it does not affect the injured area.
- Subject has a painful syndrome (e.g. sciatica) or cervical spine disorder leading to a nerve entrapment syndrome or other medical problem that in the investigator's opinion may interfere with pain measurement of the target joint.
- Subject has active skin lesions or disease at the intended site of study medication application, which may be covered by the patch. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin.
- Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
- Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
Terapi med placebo
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Once daily application of a patch for 14 days
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Eksperimentell: MRX-7EAT
Terapi med eksperimentelt medikament
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Once daily application of a patch for 14 days
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.
Tidsramme: 7 days
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7 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Yuji Kuwabara, IL Pharma
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2011
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
5. januar 2012
Først innsendt som oppfylte QC-kriteriene
5. januar 2012
Først lagt ut (Anslag)
9. januar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2018
Sist bekreftet
1. oktober 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MRX-7EAT-2006
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .