PseudoachondroplasiaPhase 2NCT03866200
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
A Phase 2 study testing resveratrol in people with Pseudoachondroplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pseudoachondroplasia
- What is being tested?
- resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2019to 28 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
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.
- Conditions
- Pseudoachondroplasia
- Being tested
- resveratrol, Placebo
- Keywords
- resveratrol, joint pain
- Medical subject headings
- Pseudoachondroplasia, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDrug
Also called resverages super berry tonic
125 mg/day or 5 ml once per day for 90 days
PlaceboDrug
5 ml once per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: resveratrol; Drug: 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. Receives: Drug: resveratrol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as Assessed by Numeric Pain Rating Scale
total score 0-10 with higher scores indicating greater pain
Measured: 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)
total score 0-100 with higher scores indicating better outcome
Measured: baseline, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start29 Jun 2019
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Why it stopped: Inability to recruit target number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PseudoachondroplasiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Posey, The University of Texas Health Science Center, Houston
- Investigators
- Karen Posey, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866200
- Sponsor's protocol ID
- HSC-MS-17-0573
- Status last verified
- Nov 2022
- First submitted
- 5 Mar 2019
- Last updated
- 9 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
- ClinicalTrials.gov ID
- NCT03866200
- Acronym / sponsor ID
- HSC-MS-17-0573
- Conditions
- Pseudoachondroplasia
- Keywords
- resveratrol, joint pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit target number
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 9 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol, Then Placebo | Experimental | Drug: resveratrol, Drug: PlaceboParticipants 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 comparator | Drug: resveratrol, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resveratrolAlso: resverages super berry tonic125 mg/day or 5 ml once per day for 90 days | Drug | Placebo, Then Resveratrol, Resveratrol, Then Placebo |
| Placebo5 ml once per day for 90 days | Drug | Placebo, Then Resveratrol, Resveratrol, Then Placebo |
Primary outcome
Pain as Assessed by Numeric Pain Rating Scale
Time frame: baseline, 30 days, 60 days, 90 days
total score 0-10 with higher scores indicating greater pain
1 secondary outcome
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
Time frame: baseline, 30 days, 60 days, 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudoachondroplasia
RecruitingObservational study
Serum Fetuin-A and COMP Levels in Knee Osteoarthritis
Knee Osteoarthritis, Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Posey, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing resveratrol in people with Pseudoachondroplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as Assessed by Numeric Pain Rating Scale (time frame: baseline, 30 days, 60 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.