Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Phase 2

Terminated

• Conditions: Pseudoachondroplasia
• Interventions: Drug: resveratrol; Drug: Placebo

• Registration Number: NCT03866200
• Lead Sponsor: 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. Another goal of this study is to evaluate side effects in this population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Study Start: 2019-06-29
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Disposition First Submitted: 2021-11-16
• Disposition First Submitted QC: 2021-11-16
• Disposition First Posted: 2021-11-19
• Status Verified: 2022-11
• Results First Submitted: 2022-11-18
• Results First Submitted QC: 2022-11-18
• Last Update Submitted: 2022-11-18
• Results First Posted: 2022-12-09
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Resveratrol, Then Placebo	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.
Placebo, Then Resveratrol	Placebo	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.
Placebo, Then Resveratrol	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.
Resveratrol, Then Placebo	resveratrol	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.

Primary Outcome Measures

Name	Time	Method
Pain as Assessed by Numeric Pain Rating Scale	baseline, 30 days, 60 days, 90 days	total score 0-10 with higher scores indicating greater pain

Secondary Outcome Measures

Name	Time	Method
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	total score 0-100 with higher scores indicating better outcome

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States