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Does Nifedipine 60 mg per day per os reduce the complaints of chronic chilblains?

Does Nifedipine 60 mg per day per os reduce the complaints of chronic chilblains? - NCCC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34714
Enrollment
50
Registered
2010-07-27
Start date
2010-11-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Chronic chilblains

Interventions

The intervention which is compared to the placebo consists of the oral administration 30mg nifedipine with regulated release once a day for two weeks and twice a day for four weeks.

Sponsors

Huisartspraktijk Souwer
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older; able to understand and follow instructions; Complaints of chronic pernio for at least 3 weeks at inclusion: itching or painful blue-red discolorated lesions at fingers and/or toes, other localisations at the feet or lateral side of the thighs ("the Kibes"). The lesions may be swollen and ulceration may be present but is not obligitory. Onset of complaints is in the period November to Februari.

Exclusion criteria

Exclusion criteria: Known inflamatory disease (RA, SLE etcetera); pregnancy; lactation; Use of Nifidipine or another calcium antagonis; hypotension (bloodpressure lower than 110/60, angina pectoris, recent myocardial infection (less than 1 month), heart failure, known liver or kidney failure, severe gastro-intentinal stricturation; use of rifampicine, fenytoin, cimetidine or ranitidine.

Design outcomes

Primary

MeasureTime frame
We consider the intervention effective if a reduction of the experienced complaints is found, displayed in a decline of the score "complaint" with at least 10 mm on the visual analogue scale concerned. "Complaint" is defined as Max (itch,pain): the Vas score for or itch or pain, depending on the highest score.

Secondary

MeasureTime frame
Secondary we register scores for impairment and the experienced side effects: headache and dizziness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)