Recruiting
Phase 1
Phase 2

Pregabalin

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02482818

Conditions

Cough

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pregabalin

Control-Placebo

Study Details

Brief summary:

The purpose of this study is to determine if Pregabalin, a medication used for the treatment of seizures and chronic pain, can be used to effectively treat people who suffer from non-asthmatic chronic cough (cough lasting over 8 weeks).

Conditions

Cough

Study ID

NCT02482818

Start date

Sep, 2015

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of non-asthmatic chronic cough defined as a cough experienced for a period of at least 8 weeks
  • Negative methacholine challenge (within past year)
  • Chest x-ray with absence of gross abnormality that could justify the cough or be a cause for the cough (within past 6 months)
  • Male or female 18 years or older
  • Willing and able to limit to 1 or less alcohol beverage per day (example: 360 ml of beer or 330 ml of cooler or 120 ml of wine)

Exclusion Criteria:

  • Concurrent use of Gabapentin or Pregabalin for other indications (seizure disorder, chronic pain)
  • History of allergy / intolerance or adverse effect with Gabapentin or Pregabalin.
  • Concurrent use of central nervous system depressants (i.e. opioids or benzodiazepines)
  • Not able to limit daily alcohol intake as recommended in the inclusion criteria
  • Creatinine clearance < 60ml/min within past three months
  • Current Smoker or has been quit less than 8 weeks
  • Symptoms of post nasal drip
  • History of gastroesophageal reflux. Only participants with untreated Gastroesophageal Reflux Disease (GERD) or less than 8 weeks of therapy will be excluded.
  • Symptoms of upper airway cough syndrome
  • ACE inhibitor use
  • Allergy to citric acid
  • Pregnant or nursing women
  • History of angioedema or congestive heart failure

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control-Placebo

Administration of Placebo (Lactose instead of Pregabalin) pills in an increasing dose regimen followed by a decreasing dose regimen over 35 days during a 42 day trial.

Initially an increasing dosage of placebo (Lactose) will be administered. On Visit 1 an increasing dose (25 mg twice a day for 3 days, then 50 mg twice a day for 2 days and then 75 mg twice a day for 2 days).

Eight days after initial placebo administration, following an assessment by the Doctor of how well subjects are doing on their (drug or placebo), the study placebo will be increased to 100 mg twice a day.

Twenty eight days after initial placebo administration subjects will begin to receive the study placebo in a reducing dose regimen for 7 days then follow up at day 42.

experimental: Pregabalin

Administration of Pregabalin in an increasing dose regimen followed by a decreasing dose regimen over 35 days during a 42 day trial.

Initially an increasing dosage of Pregabalin will be administered. On Visit 1 an increasing dose (25 mg twice a day for 3 days, then 50 mg twice a day for 2 days and then 75 mg twice a day for 2 days).

Eight days after initial medication administration, following an assessment by the Doctor of how well subjects are doing on the medication, the study medication will be increased to 100 mg twice a day.

Twenty eight days after initial drug administration subjects will begin to receive the study medication in a reducing dose regimen for 7 days.

Forty two days after initial drug administration the Doctor will meet with subjects to follow up.

Interventions

Pregabalin

Increasing dose regimen depending on tolerability followed by decreasing dose regimen.

Control-Placebo

A control substance, Lactose is administered in place of Pregabalin.

Primary outcome measure

  • Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire) [ Time Frame: 42 days ]

Central Contacts and Locations

Central contacts

Kayvan Amjadi, MD

613-798-5555kamjadi@toh.on.ca

Nha Voduc, MD

613-737-8899nvoduc@toh.on.ca

Locations

The Ottawa Hospital (General and Civic Campuses)

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Isabelle Seguin

613-737-8811iseguin@ohri.ca

Principal Investigator:

Kayvan Amjadi, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 25, 2020

Last verified

Sep, 2020

Keywords

  • chronic cough
  • cough hypersensitivity
  • Lyrica
  • Pregabalin
  • cough reflex sensitivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-09-25.