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MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF PARALLEL GROUPS, TO COMPARE THE EFFECTIVENESS AND TOLERABILITY OF VALDECOXIB VS. DICLOFENACO IN THE ANKLE SPLINT

MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF PARALLEL GROUPS, TO COMPARE THE EFFECTIVENESS AND TOLERABILITY OF VALDECOXIB VS. DICLOFENACO IN THE ANKLE SPLINT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-063-02
Enrollment
20
Registered
2002-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Valdecoxib 40 mg will be administered twice a day on the first day and 40 mg once a day until the seventh day. Group name:Diclofenac 75 mg Type of group
Diclofenac 75 mg will be administered twice daily for seven days.

Sponsors

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men or women> 18 years old with the legal age required to grant their consent. Women who are postmenopausal or surgically sterilized, or who have had a urine pregnancy test with a negative result before randomization.Men or women> 18 years old with the legal age required to grant their consent. Women who are postmenopausal or surgically sterilized, or who have had a urine pregnancy test with a negative result before randomization.

Exclusion criteria

Exclusion criteria: Clinical evidence of complete rupture of the ligaments of the ankle (sprain of third degree). Requires bed rest, hospitalization, surgical intervention to ankle injury or complete non-removable cast of any kind. presence of bilateral ankle injury or ipsilateral ankle injury and knee. A similar injury to the same joint suffered in the last six months

Design outcomes

Primary

MeasureTime frame
Outcome name:Visual Analogue Scale Measure:Evaluation of the Ankle Pain made by the Patient using a Visual Analogue Scale, measured on a scale of 0-100 mm. Timepoints:4 day

Secondary

MeasureTime frame
Outcome name:Visual Analogue Scale Measure:The Ankle Pain Assessment performed by the Patient using a Visual Analogue Scale supporting the weight on Day 7 Timepoints:day 7

Countries

Argentina, Chile, Colombia, Mexico, Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)