NCT03866200

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 29, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 9, 2022

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

March 5, 2019

Results QC Date

November 18, 2022

Last Update Submit

November 18, 2022

Conditions

Pseudoachondroplasia

Keywords

resveratroljoint pain

Outcome Measures

Primary Outcomes (1)

  • Pain as Assessed by Numeric Pain Rating Scale

    total score 0-10 with higher scores indicating greater pain

    baseline, 30 days, 60 days, 90 days

Secondary Outcomes (1)

  • Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)

    baseline, 30 days, 60 days, 90 days

Study Arms (2)

Resveratrol, Then Placebo

EXPERIMENTAL

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: resveratrolDrug: Placebo

Placebo, Then Resveratrol

PLACEBO COMPARATOR

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: resveratrolDrug: Placebo

Interventions

resveratrolDRUG

125 mg/day or 5 ml once per day for 90 days

Also known as: resverages super berry tonic
Placebo, Then ResveratrolResveratrol, Then Placebo
PlaceboDRUG

5 ml once per day for 90 days

Placebo, Then ResveratrolResveratrol, Then Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

PseudoachondroplasiaArthralgia

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Results Point of Contact

Title
Karen Posey, PhD
Organization
The University of Texas Health Science Center at Houston
karen.posey@uth.tmc.edu
713-500-5786

Study Officials

  • Karen Posey, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

June 29, 2019

Primary Completion

October 28, 2020

Study Completion

October 28, 2020

Last Updated

December 9, 2022

Results First Posted

December 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)