Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03866200
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Posey, The University of Texas Health Science Center, Houston

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 1, 2021


Arm Intervention/treatment
Experimental: resveratrol Drug: resveratrol
125 mg/day or 5 ml once per day for 90 days
Other Name: resverages super berry tonic

Placebo Comparator: Placebo Drug: Placebo
5 ml once per day for 90 days




Primary Outcome Measures :
  1. change in pain as assessed numeric pain rating scale [ Time Frame: baseline, 30 days ]
    total score 0-10 with higher scores indicating greater pain

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

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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

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


Contacts
Layout table for location contacts
Contact: Karen Posey, PhD 7135005786 karen.posey@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
University of Texas Health Science Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Karen Posey    713-500-5786    karen.posey@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Karen Posey, PhD University of Texas

Layout table for additonal information
Responsible Party: Karen Posey, Assoc. Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03866200     History of Changes
Other Study ID Numbers: HSC-MS-17-0573
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Achondroplasia
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias
Genetic Diseases, Inborn
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents