Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Pseudoachondroplasia Clinical Trial

Official title:

Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03866200
• Other study ID #: HSC-MS-17-0573
• Status: Terminated
• Phase: Phase 2
• Start date: June 29, 2019
• Est. completion date: October 28, 2020

Study information

• Verified date: November 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 28, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Achondroplasia
• Pseudoachondroplasia

Intervention

Drug:
• resveratrol
125 mg/day or 5 ml once per day for 90 days
• Placebo
5 ml once per day for 90 days

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	baseline, 30 days, 60 days, 90 days