NCT01290510

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

January 28, 2011

Last Update Submit

September 21, 2011

Conditions

Tendinopathy

Keywords

tendinopathyhyaluronantendonhyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35

    Baseline and Day 35

Secondary Outcomes (14)

  • Visual Analogue Scale of pain (VAS; 100 mm) on day 7

    On Day 7

  • Visual Analogue Scale of pain (VAS; 100 mm) on day 90

    On Day 90

  • Clinical parameters at baseline

    At baseline

  • Clinical parameters on day 7

    On Day 7

  • Clinical parameters on day 35

    On Day 35

  • +9 more secondary outcomes

Study Arms (1)

hyaluronic acid sodium salt

EXPERIMENTAL
Device: hyaluronic acid sodium salt

Interventions

hyaluronic acid sodium saltDEVICE

Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

hyaluronic acid sodium salt

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between 18 and 75 years of age and good general health condition.
  • Signed written informed consent.
  • Painful tendinopathy since ≥ 6 weeks.
  • Pain according to Visual Analogue Scale (VAS; 100 millimetres (mm)) ≥ 40 mm.
  • Ensured compliance of subjects for study period.

You may not qualify if:

  • Treatment with any investigational product within 4 weeks prior to study entry.
  • Patients with known hypersensitivity to the products (that is active compound and excipients) or any component or procedure used in the study.
  • Severe intercurrent illness (for example: uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
  • Concomitant disease at study relevant site influencing study evaluation.
  • List of diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
  • List of concomitant medications not allowed.
  • Patients treated with: systemic and/or local steroids within the last 4 weeks, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
  • Recent history of drug and/or alcohol abuse (within the last 6 months).
  • List of contra-indications to the treatment.
  • Pregnant or lactating females.
  • Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner during the treatment period and the first 4 weeks follow-up period.
  • Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and or non completion of the study according to investigator's judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zentrum für Orthopädie und Sportmedizin München

Munich, Bavaria, 80335, Germany

Location

Orthopädische Gemeinschaftspraxis Elisengalerie

Aachen, North Rhine-Westphalia, 52062, Germany

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Nils Lynen, Dr. med.

    Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

September 22, 2011

Record last verified: 2011-09

Locations

DE(2)