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Trial record 9 of 13 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Recruitment Status : Withdrawn (Sponsor decision.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

Tracking Information
First Submitted Date December 22, 2017
First Posted Date January 8, 2018
Last Update Posted Date September 20, 2018
Estimated Study Start Date October 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2018)
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.
Original Primary Outcome Measures
 (submitted: January 5, 2018)
VAS-100 of DU & RP severity over the previous week assessed by patient & MD [ Time Frame: 28 days ]
Change in patient & MD reported value
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: January 5, 2018)
  • Change in RP and DU interference in daily activities as measured by VAS-100 in SHAQ. [ Time Frame: 28 days ]
    SHAQ
  • VAS-100 of DU & RP severity over the previous week assessed by patient & MD [ Time Frame: 56 days ]
    Change in patient & MD reported value
  • Change in RP and DU interference in daily activities as measured by VAS-100 [ Time Frame: 56 days ]
    SHAQ
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tadalafil-Delivra and Raynaud's Phenomenon
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
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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Raynaud Phenomenon
Intervention Other: Observation of treatment with Tadalafil-Delivra
Tadalafil 2% in a Delivra base (Transdermal Application)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 18, 2018)
0
Original Estimated Enrollment
 (submitted: January 5, 2018)
30
Estimated Study Completion Date September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03393325
Other Study ID Numbers TAD-Sc-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
Collaborators Delivra, Inc.
Investigators
Principal Investigator: Janet E Pope, MD PhD St. Joseph's Health Care, London, ON
PRS Account Lawson Health Research Institute
Verification Date September 2018