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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pseudoachondroplasia Drug: resveratrol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Actual Study Start Date : June 29, 2019
Actual Primary Completion Date : October 28, 2020
Actual Study Completion Date : October 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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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): NCT03866200


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Karen Posey, PhD University of Texas
  Study Documents (Full-Text)

Documents provided by Karen Posey, The University of Texas Health Science Center, Houston:
Study Protocol and Statistical Analysis Plan  [PDF] May 15, 2020

More Information
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Responsible Party: Karen Posey, Assoc. Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03866200    
Other Study ID Numbers: HSC-MS-17-0573
First Posted: March 7, 2019    Key Record Dates
Results First Posted: December 9, 2022
Last Update Posted: December 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Posey, The University of Texas Health Science Center, Houston:
resveratrol
joint pain
Additional relevant MeSH terms:
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Achondroplasia
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias
Genetic Diseases, Inborn
 Resveratrol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Platelet Aggregation Inhibitors