Minocycline for the Prevention of Post-operative Intercostal Neuralgia

U

University of Adelaide

Status and phase

Unknown
Phase 2

Conditions

Post-operative Intercostal Neuralgia

Treatments

Drug: Minocycline

Study type

Interventional

Funder types

Other

Identifiers

NCT01314482
U1111-1119-6985

Details and patient eligibility

About

In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.

Full description

The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.

Enrollment

116 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female
  • Aged 18 years or older
  • Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
  • Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
  • Negative pregnancy test at screening for women of child bearing potential
  • Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
  • Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
  • Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period

Exclusion criteria

  • Pregnant or breast feeding
  • Known allergy to minocycline and other tetracycline antibiotics
  • Pre-existing neuralgic pain condition in area designated for operation
  • Physical abnormality in area designated for operation
  • Taking disallowed concomitant medication
  • Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min
  • Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
  • Diagnosis of systemic lupus erythematosus
  • Recent diagnosis of enterocolitis or colitis
  • Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
  • Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
  • History of major psychiatric disorder not medically controlled

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

116 participants in 1 patient group

Minocycline
Experimental group
Treatment:
Drug: Minocycline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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