NCT02139319

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

May 13, 2014

Last Update Submit

August 24, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events

    Up to 6 weeks

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

Single intra-articular injection

Drug: Botulinum toxin

Placebo

PLACEBO COMPARATOR

Single intra-articular injection

Drug: Placebo

Interventions

Botulinum toxinDRUG
Botulinum toxin
PlaceboDRUG
Placebo

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of the knee
  • Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
  • Pain score ≥40 mm of the index knee
  • Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen

You may not qualify if:

  • Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
  • Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
  • Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
  • A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Q-Med AB

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 25, 2022

Record last verified: 2014-08

Locations

GB(1)