Efficacy and safety of ibuprofen 5% gel compared to placebo gel in patients who have uncomplicated ankle injuries with pain

• Register: EUCTR
• Last refreshed on: 3 December 2012
• Main ID: EUCTR2011-004496-37-LT
• Date of registration: 28/11/2011
• Prospective Registration: Yes
• Primary sponsor: Orion Pharma
• Public title: Efficacy and safety of ibuprofen 5% gel compared to placebo gel in patients who have uncomplicated ankle injuries with pain
• Scientific title: A RANDOMISED, MULTICENTRE, TWO-ARM, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, COMPARATIVE EFFICACY AND SAFETY CLINICAL STUDY OF IBUPROFEN 5% GEL IN ADULT HUMAN PATIENTS WITH PAIN RELATED TO UNCOMPLICATED ANKLE INJURIES - Ibugel
• Date of first enrolment: 14/02/2012
• Target sample size: 62
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004496-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland, Lithuania

Contacts

• Name: [e-mail]
• Affiliation: Orion Corporation Orion Pharma

• Name: [e-mail]
• Affiliation: Orion Corporation Orion Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent (IC) obtained.
2. Male and female patients, age in the range of 18-45 years (inclusive).
3. Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
4. Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
5. Patients with normal or clinically non-significant findings as determined by baseline history, physical examination and vital signs (blood pressure, heart rate and axillary temperature).
6. Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
7. Negative urine pregnancy test (for females only).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drug (NSAID).
2. Known history of asthma.
3. Known history of gastric or peptic ulcer or bleeding.
4.Known history of malignancy or other serious diseases.
5. Known history of skin allergy.
6. Known history of cardiac, renal or hepatic insufficiency.
7. Presence of bruises or rash on the skin of ankle.
8. Presence of skin lesions like eczema or psoriasis.
9. Arthritis in the same joint.
10. Alcohol use during the study period or within 48 hours before the study enrolment.
11. Patients judged unable to use the VAS for pain reliably.
12. Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
13. Other pain killers than rescue medication to be taken during the study.
14. Recurrent sprain at the same joint during the last 6 months.
15. Anticoagulant therapy.
16. Physiotherapy during study period.
17. Open wounds, infected skin or fracture.
18. Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the patient.
19. Pregnant or lactating females.
20. Participation in a drug or device study within 90 days before the study enrolment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Pain related to uncomplicated ankle injuries
MedDRA version: 14.1 Level: LLT Classification code 10002545 Term: Ankle injury System Organ Class: 10022117 - Injury, poisoning and procedural complications

Intervention(s)

Trade Name: Ibuprofeno Farmasierra 5% gel
Pharmaceutical Form: Gel
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50.0-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

Primary end point(s): • Visual analogue scale (VAS) pain score change over time from baseline (day 0 before treatment administration) to day 7

Main Objective: The primary objective of the study is to evaluate the efficacy of Ibuprofen 5% gel versus placebo gel in human adult patients for the treatment of pain related to uncomplicated ankle injuries.

Secondary Objective: The secondary objective of the study is to evaluate the safety of Ibuprofen 5% gel compared with placebo gel in human adult patients.

Timepoint(s) of evaluation of this end point: Only measurements from the study visits (day 0, 3 and 7) will be included in the analysis.

Secondary Outcome(s)

Secondary end point(s): • Percentage VAS pain score change from baseline separately to day 3 and 7.
• Area under VAS curve according to study visit measurements and patient diary from baseline separately to day 3 and 7 morning assessment.
• Proportions of responders separately at day 3 and 7.
• Time to reduction of 50% in pain score from baseline.
• Proportion of patients who needed rescue medication during the study.
• Change in Verbal rating scale (VRS) scores from baseline separately to day 3 and 7.
- Functional impotence (absent, slight, moderate, severe).
- Single leg load-bearing on the injured foot (possible without pain, possible with pain, impossible).
- Assessment of pain (absent, slight, moderate, severe) by the investigator: pain at rest, pain under passive tension, pain under active tension, and pain on palpation.
• Overall assessment of efficacy (excellent, good, poor) separately at day 3 and 7 by the patient.
• Overall assessment of efficacy (excellent, good, poor) separately at day 3 and 7 by the investigator.
• Change in peri-articular oedema (difference in perimeter between the injured and healthy ankle) over time from baseline to day 7.
• The need for rescue medication.

Tolerability assessments:
• Condition of the skin (normal, abnormal) at day 0, 3 and 7
• Overall assessment of tolerability by patient (excellent, good, acceptable, poor) at day 3 and 7
• Overall assessment of tolerability by investigator (excellent, good, acceptable, poor) at day 3 and 7

Safety assessments:
• Physical examination including general and systemic examination and vital signs monitoring (blood pressure, heart rate and axillary temperature in sitting posture) will be done at day 0, 3 and 7.
• Adverse event (AE) monitoring will be done at every visit. Patients will maintain a patient diary to record AEs and concomitant medications.

Timepoint(s) of evaluation of this end point: From day 0 to day 7

Secondary ID(s)

2011-004496-37-FI

0028021

Source(s) of Monetary Support

Orion Pharma