Raynaud's PhenomenonPhase 3NCT01117298
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
A Phase 3 study testing Tadalafil in people with Raynaud's Phenomenon and Digital Ulcers, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 4 sites in India.
Trial summary
Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Raynaud's Phenomenon, Digital Ulcers, Scleroderma
- What is being tested?
- Tadalafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesIndia
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.
Who cannot join
- Patients with:
- Symptomatic orthostatic hypotension,
- Evidence of current malignancy,
- History of sympathectomy,
- Upper extremity deep vein thrombosis or lymphedema within 3 months,
- Recent surgical procedure requiring general anesthesia,
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- Acute Myocardial Infarction, unstable angina, strokes and transient ischemic attacks within the past three months,
- Smoking,
- Use of any investigational drug within 30 days of the study sessions,
- Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice,
- Patients taking alcohol,
- Patients with bleeding disorders
- Significant active peptic ulceration,
- Current pregnancy,
- Current breast-feeding.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Medicine Unit II, PGIMER
Chandigarh, Punjab
Immunology Rheumatology Unit, IPGMER
Kolkata, West Bengal
Department of Immunology, SGPGIMS
Lucknow, Uttar Pradesh, 226014
Department of Clinical Immunology, Army R&R hospital
New Delhi, ND
About this study
Official title: A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study
Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.
- Conditions
- Raynaud's Phenomenon, Digital Ulcers, Scleroderma
- Being tested
- Tadalafil, Placebo
- Keywords
- Raynaud's phenomenon, ischemic ulcers, digital ulcers, digital infarcts, gangrene, vasodilators, endothelial dysfunction, scleroderma
- Medical subject headings
- Raynaud Disease, digital ulcers, Scleroderma, Diffuse, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called Tadalis
Tab Tadalafil, 20 mg alternate day for 8 weeks
PlaceboDrug
Tab Placebo every alternate day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Not described Receives: Drug: Tadalafil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily frequency, duration and severity of Raynaud's phenomenon
Measured: Baseline and 8 weeks
Appearance or healing of digital ulcers
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Improvement in health assessment questionnaire
Measured: Baseline and 8 weeks
Improvement in scleroderma specific health assessment questionnaire
Measured: Baseline and 8 weeks
Improvement in quality of life
Measured: Baseline and 8 weeks
Improvement in biomarkers of endothelial dysfunction
Measured: Baseline and 8 weeks
Improvement in flow mediated dilatation
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud's PhenomenonStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Collaborators
- Institute of Postgraduate Medical Education and Research, Post Graduate Institute of Medical Education and Research, Chandigarh, Army Hospital Research And Referral, India
- Investigators
- Parasar Ghosh, MD, DM, Principal investigator, IPGMER, KolkattaAman Sharma, MD, Principal investigator, PGIMER, ChandigarhDarshan S Bhakuni, MD, Principal investigator, Army R&R Hospital, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117298
- Sponsor's protocol ID
- B22:A15:PGI/DM/EC/40/7.11.2007
- Status last verified
- May 2010
- First submitted
- 3 May 2010
- Last updated
- 10 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.
PubMed 37929840
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study
- ClinicalTrials.gov ID
- NCT01117298
- Acronym / sponsor ID
- B22:A15:PGI/DM/EC/40/7.11.2007
- Conditions
- Raynaud's Phenomenon, Digital Ulcers, Scleroderma
- Keywords
- Raynaud's phenomenon, ischemic ulcers, digital ulcers, digital infarcts, gangrene, vasodilators, endothelial dysfunction, scleroderma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Collaborators
- Institute of Postgraduate Medical Education and Research, Post Graduate Institute of Medical Education and Research, Chandigarh, Army Hospital Research And Referral, India
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.
Key exclusion criteria (15 listed)
- Symptomatic orthostatic hypotension,
- Evidence of current malignancy,
- History of sympathectomy,
- Upper extremity deep vein thrombosis or lymphedema within 3 months,
- Recent surgical procedure requiring general anesthesia,
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 |
|---|---|---|
| TadalafilAlso: TadalisTab Tadalafil, 20 mg alternate day for 8 weeks | Drug | Tadalafil |
| PlaceboTab Placebo every alternate day for 8 weeks | Drug | Placebo |
Primary outcome
Daily frequency, duration and severity of Raynaud's phenomenon
Time frame: Baseline and 8 weeks
Appearance or healing of digital ulcers
Time frame: Baseline and 8 weeks
5 secondary outcomes
Improvement in health assessment questionnaire
Time frame: Baseline and 8 weeks
Improvement in scleroderma specific health assessment questionnaire
Time frame: Baseline and 8 weeks
Improvement in quality of life
Time frame: Baseline and 8 weeks
Improvement in biomarkers of endothelial dysfunction
Time frame: Baseline and 8 weeks
Improvement in flow mediated dilatation
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2010.
- Derived from this study: PubMed 37929840Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.
- Related InfoLink provided by the sponsor.
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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.
Parasar Ghosh, MD, DM principal investigator
IPGMER, Kolkatta
Aman Sharma, MD principal investigator
PGIMER, Chandigarh
Darshan S Bhakuni, MD principal investigator
Army R&R Hospital, New Delhi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil in people with Raynaud's Phenomenon and Digital Ulcers, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 4 sites in India.
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 1 inclusion and 15 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: finished, as of the sponsor's last update on 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily frequency, duration and severity of Raynaud's phenomenon (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117298, which also lists 1 linked publication.
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 10 May 2010.