Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Pseudoachondroplasia

Treatments: Drug: Placebo; Drug: resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT03866200

HSC-MS-17-0573

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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6 participants in 2 patient groups, including a placebo group

Resveratrol, Then Placebo

Experimental group

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.

Treatment:

Drug: resveratrol

Drug: Placebo

Placebo, Then Resveratrol

Placebo Comparator group

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.

Treatment:

Drug: resveratrol

Drug: Placebo