Trial record 2 of 49 for:    Open Studies | "Tendinopathy"

Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by TRB Chemedica AG
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG
ClinicalTrials.gov Identifier:
NCT01954108
First received: September 26, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.


Condition Intervention
Tendinopathy
Device: hyaluronic acid sodium salt
Device: ESWT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Resource links provided by NLM:


Further study details as provided by TRB Chemedica AG:

Primary Outcome Measures:
  • Victorian Institute of Sports Assessment-Achilles (VISA-A score) [ Time Frame: Day 90 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.


Secondary Outcome Measures:
  • Victorian Institute of Sports Assessment-Achilles (VISA-A score) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score) [ Time Frame: Day 7 (plus or minus 1 day) ] [ Designated as safety issue: No ]
    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score) [ Time Frame: Day 28 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score) [ Time Frame: Day 180 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

  • Visual Analogue Scale of pain (VAS; 100 mm) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.

  • Visual Analogue Scale of pain (VAS; 100 mm) [ Time Frame: Day 7 (plus or minus 1 day) ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.

  • Visual Analogue Scale of pain (VAS; 100 mm) [ Time Frame: Day 28 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.

  • Visual Analogue Scale of pain (VAS; 100 mm) [ Time Frame: Day 90 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.

  • Visual Analogue Scale of pain (VAS; 100 mm) [ Time Frame: Day 180 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.

  • Patient's and investigator's global evaluation of study-relevant tendon complaints [ Time Frame: Day 7 (plus or minus 1 day) ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Patient's and investigator's global evaluation of study-relevant tendon complaints [ Time Frame: Day 28 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Patient's and investigator's global evaluation of study-relevant tendon complaints [ Time Frame: Day 90 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Patient's and investigator's global evaluation of study-relevant tendon complaints [ Time Frame: Day 180 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Clinical Parameters [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.


  • Clinical Parameters [ Time Frame: Day 7 (plus or minus 1 day) ] [ Designated as safety issue: No ]
    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.


  • Clinical Parameters [ Time Frame: Day 28 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.


  • Clinical Parameters [ Time Frame: Day 90 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.


  • Clinical Parameters [ Time Frame: Day 180 (plus or minus 3 days) ] [ Designated as safety issue: No ]
    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.


  • Frequency of test product-related Adverse Events [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ESWT (Extracorporal Shock Wave Therapy)
Three applications in weekly interval.
Device: ESWT
Active Comparator: hyaluronic acid sodium salt
Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
Device: hyaluronic acid sodium salt
Other Name: OSTENIL® TENDON

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients between 18 and 75 years of age.
  • Good general health condition.
  • Signed written informed consent.
  • Painful Achilles midportion tendinopathy since more or equal than 6 weeks.
  • Pain according to VAS (Huskisson, 100 mm) more or equal than 40 mm.
  • Ensured compliance of subjects over the whole study period.

Exclusion Criteria:

  • Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
  • Infection or relevant skin disease at study relevant site.
  • Blood coagulation disorder or intake of blood thinner (e.g. Marcumar).
  • Known hypersensitivity to hyaluronic acid (HA) preparations or to the constituents mannitol, sodium chloride, disodium phosphate and sodium dihydrogenphosphate.
  • Contra-indications for ESWT application in study relevant area (e.g. recent surgery, malignant tumour, local osteomyelitis or open epiphysis).
  • Severe intercurrent illness (e.g. 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 (e.g. insertion tendinopathy at Achilles tendon) influencing study evaluation.
  • Diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
  • Intake of concomitant medications not allowed which might interfere with the functional assessment of the study (e.g. immunosuppressive drugs within the last 3 months).
  • Previous therapies (except non-steroidal anti-inflammatory drugs (NSAID)) at study relevant site within the last 4 weeks prior to study inclusion.
  • Use of NSAIDs within the last week prior to study treatment.
  • Recent history of drug and/or alcohol abuse (within the last 6 months).
  • Pregnant or lactating females.
  • Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index of at least 1 (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 4 weeks of follow-up period.
  • Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
  • 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 (e.g. illiteracy, insufficient knowledge of local language).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954108

Contacts
Contact: Petra Dobner, Dr. +49 89-46 14 83 20 dobner@trbchemedica.de
Contact: Raphaela Geiger +49 89-46 14 83 27 geiger@trbchemedica.de

Locations
Belgium
Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie Recruiting
Edegem, Belgium, 2650
Contact: Thierry De Vroey, Dr.    +32 (0)3 / 82 13 196    Thierry.DeVroey@uza.be   
Contact: Gaëtane Stassijns, Prof. Dr.    +32 (0)3 / 82 13 983    gaetane.stassijns@uza.be   
Principal Investigator: Thierry De Vroey, Dr.         
Sub-Investigator: Gaëtane Stassijns, Prof. Dr.         
Germany
Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52062
Contact: Nils Lynen, Dr.    +49 241-30 20 10    n.lynen@exinmo.de   
Contact: Imke Spiegel, Dr.    +49 241-30 20 10      
Principal Investigator: Nils Lynen, Dr.         
Sub-Investigator: Imke Spiegel, Dr.         
Sponsors and Collaborators
TRB Chemedica AG
Investigators
Principal Investigator: Thierry De Vroey, Dr. med. Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie
Principal Investigator: Nils Lynen, Dr. med. Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein
  More Information

No publications provided

Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT01954108     History of Changes
Other Study ID Numbers: OTENA-INT-2013-03, CIV-13-07-011543
Study First Received: September 26, 2013
Last Updated: December 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by TRB Chemedica AG:
tendinopathy
hyaluronan
tendon
hyaluronic acid
extracorporeal shock wave

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014