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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Primary Purpose

Pseudoachondroplasia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
resveratrol
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudoachondroplasia focused on measuring resveratrol, joint pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol, Then Placebo

Placebo, Then Resveratrol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain as Assessed by Numeric Pain Rating Scale
total score 0-10 with higher scores indicating greater pain

Secondary Outcome Measures

Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
total score 0-100 with higher scores indicating better outcome

Full Information

First Posted
March 5, 2019
Last Updated
November 18, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03866200
Brief Title
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Official Title
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit target number
Study Start Date
June 29, 2019 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoachondroplasia
Keywords
resveratrol, joint pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol, Then Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, Then Resveratrol
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
resveratrol
Other Intervention Name(s)
resverages super berry tonic
Intervention Description
125 mg/day or 5 ml once per day for 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 ml once per day for 90 days
Primary Outcome Measure Information:
Title
Pain as Assessed by Numeric Pain Rating Scale
Description
total score 0-10 with higher scores indicating greater pain
Time Frame
baseline, 30 days, 60 days, 90 days
Secondary Outcome Measure Information:
Title
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
Description
total score 0-100 with higher scores indicating better outcome
Time Frame
baseline, 30 days, 60 days, 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Posey, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

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