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TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier:
NCT01066520
First received: February 9, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.


Condition Intervention Phase
Sprain of Ankle
Drug: Traumeel S ointment
Drug: Traumeel S gel
Drug: Diclofenac gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multi-center Study on the Effectiveness of Traumeel S (Both Ointment and Gel) in Terms of Pain and Function Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

Resource links provided by NLM:


Further study details as provided by Biologische Heilmittel Heel GmbH:

Primary Outcome Measures:
  • Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 [ Time Frame: From baseline (day 1) visit to day 7 ] [ Designated as safety issue: No ]

    Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.

    The highest is the change in negative, the better are the results in absolute values.


  • Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 [ Time Frame: Day 1 to day 7 ] [ Designated as safety issue: No ]

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.

    Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.

    Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.


  • Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 [ Time Frame: From baseline (day 1) visit to day 7 ] [ Designated as safety issue: No ]

    Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.

    The highest is the change in negative, the better are the results in percentages.



Secondary Outcome Measures:
  • FAAM ADL Subscale [ Time Frame: Day 1 to 4, 14, 42 ] [ Designated as safety issue: No ]
  • FAAM Sports Subscale [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
  • Swelling ('Figure-of-eight') [ Time Frame: Day 1 to 4,7,14 ] [ Designated as safety issue: No ]
  • Physician's Assessment of Normal Function/Activity (5-point-scale) [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
  • Time to Normal Function (Training/Sports) [ Time Frame: Day 1 to 4, 7, 14, 42 ] [ Designated as safety issue: No ]
  • Global Judgment of Efficacy [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 449
Study Start Date: August 2009
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Traumeel S ointment
Traumeel S ointment 2 g, 3 times daily topical during 14 days
Drug: Traumeel S ointment
2 g, 3 times daily topical during 14 days
Other Name: Traumeel S ointment, Traumeel S gel, Diclofenac gel
Experimental: Traumeel S gel
Traumeel S gel 2 g, 3 times daily topical during 14 days
Drug: Traumeel S gel
2 g, 3 times daily topical during 14 days
Other Name: Traumeel S gel
Active Comparator: Diclofenac gel
Diclofenac gel 2 g, 3 times daily topical during 14 days
Drug: Diclofenac gel
2 g, 3 times daily topical during 14 days
Other Name: Diclofenac gel

Detailed Description:

Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female
  • Moderate (30-60 mm) to severe (>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities
  • 18 - 40 years of age
  • injury occurred within 24 hours of the first dose of study medication
  • Willing and able to give written informed consent
  • Available for the duration of the study

Exclusion Criteria:

  • Similar injury affecting the same joint within the past 6 months
  • bilateral ankle injury
  • bed rest, hospitalization, surgery use of a non-removable rigid cast
  • Clinically important abnormality for screening laboratory tests
  • Debilitating acute or chronic illness
  • Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
  • History of sensitivity to any component of the study drugs
  • Unwilling or unable to comply with all the requirements of the protocol
  • Participation in other studies within 4 weeks prior to study entry and or during the study participation
  • Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
  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: NCT01066520

Locations
Spain
MEDYR Medicina Deportiva y Rehabilitación
Madrid, Spain
Sponsors and Collaborators
Biologische Heilmittel Heel GmbH
Investigators
Study Chair: Carlos Gonzalez de Vega, MD National Coordinating Investigator
  More Information

Additional Information:
No publications provided by Biologische Heilmittel Heel GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier: NCT01066520     History of Changes
Other Study ID Numbers: TRS-ESP, 2008-007939-41
Study First Received: February 9, 2010
Results First Received: February 18, 2013
Last Updated: December 9, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by Biologische Heilmittel Heel GmbH:
ankle sprain
traumeel
diclofenac
antiinflammatory
time to normal function

Additional relevant MeSH terms:
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014