Comparison of the effect the lysine clonixinate (Dolamin ®) and ibuprofen (Advil ®) in reducing pain in patients with tendinopathy

A Randomized single-blinded, parallel group and unicentric Phase IV Clinical Study of non-inferiority, comparing the drug Lysine Clonixinate (Dolamin®) and Ibuprofen (Advil®) in reducing acute pain related to tendinopathy in patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-37jpt3

Enrollment

Unknown

Registered

2014-09-16

Start date

2012-05-23

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain related to tendinopathies.

Interventions

Comparison group: 82 patients will receive Lysine Clonixinate 125 mg, three (3) times a day, 8 (eight) in 8 hours for 7 (seven) consecutive days. Control group: 82 patients will receive ibuprofen 200

Drug

C05.651.869

M70.4

M75.3

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Volunteers be carrying from acute pain related to tendinopathy (tendinitis, tenosynovitis and bursitis of the shoulders, wrists / hands, knees and ankles / feet and require immobilization; age between 18 and 65 (sixty five) years; Indicate, in max, grade 7 in the Visual Analogue Scale (VAS) of pain; Having signed and dated the 'Informed of Consent Form' (ICF) specified for this study, prior to any participation in procedures related to it.

Exclusion criteria

Exclusion criteria: None of the patients included in this study should be carrying from acute pain related to tendinopathy at the hip; having a history of asthma or bronchospasm, nasal polyps, allergic reactions and / or induced by acetylsalicylic acid (aspirin) or other anti-inflammatory drugs; history of gastrointestinal bleeding due to the use of NSAIDs; is receiving treatment with other anti-inflammatory drugs, corticosteroids or analgesics; Is receiving treatment with oral anticoagulants, ticlopidine, heparin and thrombolytics; be pregnant and / or lactating; be hypersensitive (allergic) to any of the components of the formula; 8. Be a regular user of alcohol and barbiturates; have hepatic or renal impairment.

Design outcomes

Primary

Measure	Time frame
Compare the efficacy the Lysine Clonixinate and ibuprofen in the control the acute pain in patients with tendinopathies using a visual analogue scale (VAS) and possible adverse event reports;Lysine Clonixinate is not inferior to ibuprofen in reducing acute pain related to tendinopathy.	—

Secondary

Measure	Time frame
Compare the tolerability the Lysine Clonixinate and ibuprofen possible by reports of adverse events;Lysine Clonixinate showed similar tolerability to ibuprofen	—

Countries

Brazil

Contacts

Public ContactThales Braga

Farmoquimica S.A

tbraga@fqm.com.br+55 21 21226100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)