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Trial record 9 of 12 for:    PDE-5 inhibitors raynaud's

Tadalafil-Delivra and Raynaud's Phenomenon

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ClinicalTrials.gov Identifier: NCT03393325
Recruitment Status : Withdrawn (Sponsor decision. The study is not anticipated to start)
First Posted : January 8, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Delivra, Inc.
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).

Condition or disease Intervention/treatment
Raynaud Phenomenon Other: Observation of treatment with Tadalafil-Delivra

Detailed Description:

To determine if the feasibility of conducting a future RCT using the chosen outcome assessments in RP patients at 2 Rheumatology clinics.

Study Design:

Observation of patients prescribed Tadalafil-Delivra 2% (Tad-Del) for the treatment of RP with defined feasibility objectives and data collection through efficacy and safety assessments. Study objectives are:

  • At least 70% recruitment of eligible participants.
  • 100% data collection from at least 70% of all enrolled subjects.
  • Estimate the standard deviation(s) of all outcome assessments.

Setting/Participants:

Patients prescribed Tad-Del will be screened for study enrollment at 2 participating rheumatology clinics by the local research team. Participants that meet all the eligibility criteria will be enrolled in the study as subjects. Subjects will self-administer the medication as prescribed and return to the clinic for follow-up. Data will be collected on outcome assessments at: baseline, 1 week and at 4 to 8 weeks of treatment.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Observational Pilot Study on the Use of Tadalafil Delivra Cream in the Treatment of Raynaud's Phenomenon and Pain Associated With Digital Ulcers
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil


Intervention Details:
  • Other: Observation of treatment with Tadalafil-Delivra
    Tadalafil 2% in a Delivra base (Transdermal Application)


Primary Outcome Measures :
  1. VAS-100 of DU & RP severity over the previous week assessed by patient & MD [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]
    Visual Analogue Scale (VAS) of the severity of Digital Ulcers (DU) and Raynaud's Phenomenon (RP). The physician (MD) and patient will each independently make their own assessment on a linear 10 cm VAS scale by making a mark on the line with a pen anywhere from the left anchor "0" (indicating no disease at all) to the right anchor "10" (indicating the most severe imaginable). Both the MD and patient will complete an individual scale for RP and DU. The distance of the mark from the left anchor "0" will be recorded in mm, divided by 10 and reported as a value from 0 to 10. A total of 4 VAS scales will be completed.


Secondary Outcome Measures :
  1. Change in RP and DU interference in daily activities as measured by VAS-100 in SHAQ. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]
    Visual Analogue Scales for Raynaud's Phenomenon and Digital Ulcer interference in daily activities as measured by the patient. Both assessments are part of the Scleroderma Health Assessment Questionnaire (SHAQ). The patient will make an assessment on the linear VAS scale for each by making a mark on the line with a pen anywhere from the left anchor "Does not limit activities" to the right anchor "Very Severe limitation". The distance of the mark from the left to the right anchor will be measured in mm, divided by 10 and reported as a value from 0 to 10. There are two scales: 1 for Raynaud's Phenomena and the other for Digital Ulcer.

  2. changes in the use of concurrent RP therapy and pain medications in patients treated with Tad-Del. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]
    Concomitant medication use at the end of treatment (day 28-56) will be compared with concomitant medication use at baseline with respect to daily dose administered.

  3. All adverse Event experienced by the patient during study participation (1st to last visit) will be recorded. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]
    Adverse events will be summarized and reported at the end of treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been prescribed Tad-Delivra for the treatment of primary or secondary Raynaud's Phenomenon with or without an active digital ulcer.
Criteria

Inclusion Criteria:

  1. Adults of both genders, Age 18 to 75 years.
  2. Patients with a confirmed diagnosis of Raynaud's Phenomenon (RP).
  3. Written informed consent.
  4. The presence of 1 or more digital ulcers (DU), that is not related to calcinosis, anywhere on a finger that is symptomatic for RP- defined as a VAS pain score of ≥25mm of 100mm Or 1 -3 fingers that are symptomatic for RP under standard of care treatment (SoC). Symptomatic is defined as a VAS pain score of ≥ 25mm of 100mm.
  5. Prescribed, but not currently being treated with Tad-Del.
  6. Maintenance of a stable background of prescribed treatment for RP including vasodilators, orally administered PDE5i and pain medication. Changes to administration of this concomitant medication will be documented in the case report form (CRF).

Exclusion Criteria:

  1. Unwilling and/or incapable of adhering to the study procedures and follow-up schedule.
  2. Use of other prescribed topical treatment for RP, such as nitrates.
  3. Active infection of the index ulcer
  4. Calcinosis at the site of the index ulcer
  5. Received Iloprost or other prostacyclin treatment in the last 4 months.
  6. Unsuitable for study participation as determined by the clinical investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393325


Locations
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Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T3L9
Sponsors and Collaborators
Lawson Health Research Institute
Delivra, Inc.
Investigators
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Principal Investigator: Janet E Pope, MD PhD St. Joseph's Health Care, London, ON

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03393325     History of Changes
Other Study ID Numbers: TAD-Sc-0001
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Raynaud Disease
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents