Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

• ClinicalTrials.gov Identifier: NCT03866200
• Recruitment Status: Terminated
• First Posted: March 7, 2019
• Results First Posted: December 9, 2022
• Last Update Posted: December 9, 2022
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Karen Posey, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: March 5, 2019
• First Posted Date: March 7, 2019
• Results First Submitted Date: November 18, 2022
• Results First Posted Date: December 9, 2022
• Last Update Posted Date: December 9, 2022
• Actual Study Start Date: June 29, 2019
• Actual Primary Completion Date: October 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2022)

Pain as Assessed by Numeric Pain Rating Scale [ Time Frame: baseline, 30 days, 60 days, 90 days ]

total score 0-10 with higher scores indicating greater pain

Original Primary Outcome Measures (submitted: March 5, 2019)

• change in pain as assessed numeric pain rating scale [ Time Frame: baseline, 30 days ]
  total score 0-10 with higher scores indicating greater pain
• change in pain as assessed numeric pain rating scale [ Time Frame: baseline, 60 days ]
  total score 0-10 with higher scores indicating greater pain
• change in pain as assessed numeric pain rating scale [ Time Frame: baseline, 90 days ]
  total score 0-10 with higher scores indicating greater pain

Current Secondary Outcome Measures (submitted: November 18, 2022)

Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) [ Time Frame: baseline, 30 days, 60 days, 90 days ]

total score 0-100 with higher scores indicating better outcome

Original Secondary Outcome Measures (submitted: March 5, 2019)

• Change in health related quality of life score (HRQoL) assessed by 36-item short form health survey short form-36 (SF-36) [ Time Frame: baseline, 30 days ]
  total score 0-100 with higher scores indicating better outcome
• Change in health related quality of life score (HRQoL) assessed by 36-item short form health survey short form-36 (SF-36) [ Time Frame: baseline, 60 days ]
  total score 0-100 with higher scores indicating better outcome
• Change in health related quality of life score (HRQoL) assessed by 36-item short form health survey short form-36 (SF-36) [ Time Frame: baseline, 90 days ]
  total score 0-100 with higher scores indicating better outcome

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
• Official Title: Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
• Brief Summary: The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of this study is to evaluate side effects in this population.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pseudoachondroplasia

Intervention

• Drug: resveratrol
  125 mg/day or 5 ml once per day for 90 days
  Other Name: resverages super berry tonic
• Drug: Placebo
  5 ml once per day for 90 days

Study Arms

• Experimental: Resveratrol, Then Placebo
  Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days.
  Interventions:

  • Drug: resveratrol
  • Drug: Placebo
• Placebo Comparator: Placebo, Then Resveratrol
  Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days.
  Interventions:

  • Drug: resveratrol
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 16, 2021): 6
• Original Estimated Enrollment (submitted: March 5, 2019): 30
• Actual Study Completion Date: October 28, 2020
• Actual Primary Completion Date: October 28, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• The diagnosis of pseudoachondroplasia is based on clinical assessment either in person or by photographic review by skeletal dysplasia specialist (JTH),
• Healthy beyond pseudoachondroplasia associated complications,

Exclusion Criteria:

• Current use of resveratrol
• Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine and triazolam.
• Other non-pseudoachondroplasia related health conditions, e.g. cancers.
• Pregnancy or breastfeeding. Women must use adequate contraception during the study.
• Participation in another clinical study and/or using investigational agents.
• Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin.
• Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine, Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir, Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine, Fosphenytoin, Phenytoin or Warfarin.
• Baseline level of pain of 2 or higher on 10 point scale.
• Platelet count below 50,000 per ul on baseline complete blood count (CBC).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03866200
• Other Study ID Numbers: HSC-MS-17-0573
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Karen Posey, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karen Posey, PhD; University of Texas

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: November 2022