NCT01481610

Brief Summary

The purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (GFR) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

November 23, 2011

Last Update Submit

February 11, 2013

Conditions

Kidney Failure, ChronicArthralgia

Keywords

Kidney Failure, ChronicArthralgiaNSAIDDiclofenacLumiracoxibSafety

Outcome Measures

Primary Outcomes (1)

  • Change in GFR

    Magnitude of change in GFR (ml / min) as measured by creatinine clearance in urine over 24 hours, considering the initial and final value at the end of the study. Creatinine clearance will be measured twice: initially, prior to the first dose of medication (baseline), and again at the end of treatment (ie. 10 days after starting dose).

    Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient

Secondary Outcomes (2)

  • Use of rescue medication

    Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)

  • Subjective improvement in pain

    Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)

Study Arms (2)

Lumiracoxib group

EXPERIMENTAL

Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day) for a period of maximum 10 days, but no shorter than 7 days.

Drug: Lumiracoxib

Diclofenac group

ACTIVE COMPARATOR

Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.

Drug: Diclofenac

Interventions

LumiracoxibDRUG

Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day), for a period no longer than 10 days, but no shorter than 7 days.

Lumiracoxib group
DiclofenacDRUG

Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.

Diclofenac group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic joint pain, requiring analgesia
  • pre-existing chronic kidney injury, stage K/DOQI III (GFR 30 - 59 ml/min)
  • in a stable phase of CKD (i.e. not AKI, not hospitalized)
  • without contraindications for NSAID therapy
  • who have signed an informed consent

You may not qualify if:

  • having received any NSAID 2 weeks prior to study start
  • history of / actual PUD
  • patients with ESRD (K/DOQI IV, V or replacement therapy)
  • history of hypersensitivity or allergies to any of the treatments
  • history of / actual GI bleeding
  • with impaired liver function tests
  • using ACEI / ARB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central Sur de Alta Especialidad PEMEX

Mexico City, Mexico City, 14140, Mexico

Location

MeSH Terms

Conditions

Kidney Failure, ChronicArthralgia

Interventions

lumiracoxibDiclofenac

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Carlos Molina-Calzada, M.D.

    Petroleos Mexicanos - Servicios de Salud

    PRINCIPAL INVESTIGATOR

  • Alejandro Arce-Salinas, M.D.

    Petroleos Mexicanos - Servicios de Salud

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident - Internal Medicine Department

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 29, 2011

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

ME(1)