Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Tendinopathy Clinical Trial

Official title:

Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954108
• Other study ID #: OTENA-INT-2013-03
• Secondary ID: CIV-13-07-011543
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: November 6, 2015
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Device:
• hyaluronic acid sodium salt

• ESWT

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie	Edegem
Germany	Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein	Aachen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute of Sports Assessment-Achilles (VISA-A score)	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'.	Day 90 (plus or minus 3 days)	No
Secondary	Victorian Institute of Sports Assessment-Achilles (VISA-A score)	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'.	Day 0	No
Secondary	Victorian Institute of Sports Assessment-Achilles (VISA-A score)	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'.	Day 7 (plus or minus 1 day)	No
Secondary	Victorian Institute of Sports Assessment-Achilles (VISA-A score)	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'.	Day 28 (plus or minus 3 days)	No
Secondary	Victorian Institute of Sports Assessment-Achilles (VISA-A score)	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'.	Day 180 (plus or minus 3 days)	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm)	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'.	Day 0	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm)	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'.	Day 7 (plus or minus 1 day)	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm)	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'.	Day 28 (plus or minus 3 days)	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm)	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'.	Day 90 (plus or minus 3 days)	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm)	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'.	Day 180 (plus or minus 3 days)	No
Secondary	Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 7 (plus or minus 1 day)	No
Secondary	Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 28 (plus or minus 3 days)	No
Secondary	Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 90 (plus or minus 3 days)	No
Secondary	Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 180 (plus or minus 3 days)	No
Secondary	Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 0	No
Secondary	Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 7 (plus or minus 1 day)	No
Secondary	Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 28 (plus or minus 3 days)	No
Secondary	Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 90 (plus or minus 3 days)	No
Secondary	Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 180 (plus or minus 3 days)	No
Secondary	Frequency of test product-related Adverse Events		Up to Day 180	Yes