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CompletedNCT01496326ANTIPAINUpdated Dec 21, 2011

Osteoarthritis Topical Treatment

A Phase 2 interventional study of Ibuprofen and placebo in Osteoarthritis, sponsored by BioChemics, Inc.. Completed at 5 sites in Switzerland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-12-21.

Sponsored by BioChemics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)

02

Conditions studied

  • Osteoarthritis

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Keywords

  • Osteoarthritis
  • knee pain
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

BioChemics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • Male or female patients aged at least 40 years.
  • Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
  • Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
  • pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

  • Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
  • Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
  • Female patients who are pregnant or breast-feeding.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Ibuprofen

    Drug: Ibuprofen

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugIbuprofen

    10% ibuprofen cream formulation at a dose of 200mg

  • Drugplacebo

    2 grams of placebo cream for 14 days

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS) Pain scale

    Time frame: 14 days

07

Study locations

5 sites
  • Schaffhausen, 8200, Switzerland
  • St. Gallen, 9000, Switzerland
  • Zürich, 8001, Switzerland
  • Zürich, 8050, Switzerland
  • Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
    Zürich, 8091, Switzerland
08

References and documents

Publications

  • Varadi G, Zhu Z, Blattler T, Hosle M, Loher A, Pokorny R, Frey D, Carter SG. Randomized clinical trial evaluating transdermal Ibuprofen for moderate to severe knee osteoarthritis. Pain Physician. 2013 Nov-Dec;16(6):E749-62. PubMed 24284856 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01496326
Lead sponsor
BioChemics, Inc.
Responsible party
Sponsor
First posted
Dec 21, 2011
Start date
Feb 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Dec 21, 2011

Study contacts

Stephen Carter, Ph.D.
study director · BioChemics, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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