Study of Thymosin Beta 4 in Patients With Pressure Ulcers
Sponsor
RegeneRx Biopharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00382174
Collaborator
(none)
72
12
2
31
6
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers
Study Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 1 0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days |
Drug: Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
|
| Active Comparator: 2 3 doses of thymosin beta 4: 0.01% w/w, 0.02% w/w, and 0.1% w/w, administered topically once daily for up to 84 days |
Drug: Thymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days [Up to 84 days]
All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
Secondary Outcome Measures
- Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days [Up to 84 days]
Incidence of wound healing at the end of the study, Day 84
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Informed Consent Form signed by the patient or patient's legal representative
-
Inpatients and outpatients
-
At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure
-
Surface area between 5 and 70 cm2
-
Ulcer present and stable for at least 1 month before enrollment
Exclusion Criteria:
-
Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
-
Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
-
History of adverse events to any ingredients of study medication
-
Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
-
Arterial or venous disorder resulting in ulcerated wounds
-
Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
-
Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Advanced Wound Care | Montgomery | Alabama | United States | 36111 |
| 2 | Impact Clinical Trials | Beverly Hills | California | United States | 90211 |
| 3 | Long Beach VAMC | Long Beach | California | United States | 90822 |
| 4 | Bay Pines VA Medical Center | Bay Pines | Florida | United States | 33744 |
| 5 | A+ Research, Inc. | Miami | Florida | United States | 33115 |
| 6 | Mount Dora Research Center, Inc. | Mount Dora | Florida | United States | 32757 |
| 7 | Hines VAMC | Hines | Illinois | United States | 60141 |
| 8 | Wound Healing Laboratory Plastic Surgery UMass Medical Center | Worcester | Massachusetts | United States | 01655 |
| 9 | New York Presbyterian Hospital | New York | New York | United States | 10032 |
| 10 | University of North Carolina Hospital | Chapel Hill | North Carolina | United States | 27599 |
| 11 | New Bridge Medical Center | Warren | Pennsylvania | United States | 16365 |
| 12 | Mcguire VA Medical Center | Richmond | Virginia | United States | 23249 |
Sponsors and Collaborators
- RegeneRx Biopharmaceuticals, Inc.
Investigators
- Principal Investigator: Terry Treadwell, MD, Institute for Advanced Wound Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00382174
Other Study ID Numbers:
- SSPU
First Posted:
Sep 28, 2006
Last Update Posted:
Feb 1, 2010
Last Verified:
Jan 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers. |
|---|---|
| Pre-assignment Detail | Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin. |
| Arm/Group Title | Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses |
|---|---|---|---|
| Arm/Group Description | 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1% |
| Period Title: Overall Study | |||
| STARTED | 18 | 54 | 72 |
| COMPLETED | 14 | 37 | 51 |
| NOT COMPLETED | 4 | 17 | 21 |
Baseline Characteristics
| Arm/Group Title | Placebo | Tβ4 at 3 Doses | Total |
|---|---|---|---|
| Arm/Group Description | 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | Total of all reporting groups |
| Overall Participants | 18 | 54 | 72 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
17
94.4%
|
38
70.4%
|
55
76.4%
|
| >=65 years |
1
5.6%
|
16
29.6%
|
17
23.6%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
11.1%
|
14
25.9%
|
16
22.2%
|
| Male |
16
88.9%
|
40
74.1%
|
56
77.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
18
100%
|
54
100%
|
72
100%
|
Outcome Measures
| Title | Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days |
|---|---|
| Description | All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population |
| Time Frame | Up to 84 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses |
|---|---|---|---|
| Arm/Group Description | 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1% |
| Measure Participants | 18 | 54 | 72 |
| Number [participants] |
18
100%
|
53
98.1%
|
71
98.6%
|
| Title | Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days |
|---|---|
| Description | Incidence of wound healing at the end of the study, Day 84 |
| Time Frame | Up to 84 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was per protocol,ITT, and using LOCF |
| Arm/Group Title | Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses |
|---|---|---|---|
| Arm/Group Description | 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1% |
| Measure Participants | 18 | 54 | 72 |
| Number [Number of healed participants] |
3
16.7%
|
8
14.8%
|
11
15.3%
|
Adverse Events
| Time Frame | Adverse Events (AEs) were collected for 99 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99. | |||||
| Arm/Group Title | Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses | |||
| Arm/Group Description | 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1% | |||
All Cause Mortality |
||||||
| Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/ (NaN) | 13/ (NaN) | 18/ (NaN) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Cardiac disorders | ||||||
| Angina | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Cardiac Failure Congestive | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| General disorders | ||||||
| Chest pain | 1/18 (5.6%) | 1 | 1/53 (1.9%) | 1 | 2/71 (2.8%) | 2 |
| Pyrexia | 0/18 (0%) | 0 | 3/53 (5.7%) | 3 | 3/71 (4.2%) | 3 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Infections and infestations | ||||||
| Bacteraemia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Infected Skin Ulcer | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Lobar pneumonia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Osteomyelitis | 2/18 (11.1%) | 2 | 1/53 (1.9%) | 1 | 3/71 (4.2%) | 3 |
| Perianal Abscess | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Pneumonia | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Sepsis | 2/18 (11.1%) | 2 | 2/53 (3.8%) | 2 | 4/71 (5.6%) | 4 |
| Skin infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Urinary Tract Infection | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Urosepsis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Wound Infection staphylococcal | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Overdose | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Wound Complications | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Investigations | ||||||
| Heart Rate Increased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Psychiatric disorders | ||||||
| Affective Disorder | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Confusional State | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Respiratory Failure | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Pulmonary Embolism | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Tβ4 at 3 Doses | Placebo vs. Thymosin Beta 4 at 3 Doses | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/ (NaN) | 40/ (NaN) | 53/ (NaN) | |||
| Blood and lymphatic system disorders | ||||||
| Aneamia | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Cardiac disorders | ||||||
| Angina Pectoris | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Cardiac Failure Congestive | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Endocrine disorders | ||||||
| Hyperaldosteronism | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Eye disorders | ||||||
| Adreanal Insufficiency | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Conjunctivitis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Gastrointestinal disorders | ||||||
| Dental Caries | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Diarrhea | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Nausea | 0/18 (0%) | 0 | 3/53 (5.7%) | 3 | 3/71 (4.2%) | 3 |
| Vomiting | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| General disorders | ||||||
| Asthenia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Chest Pain | 1/18 (5.6%) | 1 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Chills | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Inflammation | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Oedema Peripheral | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Pyrexia | 1/18 (5.6%) | 1 | 8/53 (15.1%) | 8 | 9/71 (12.7%) | 9 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Immune system disorders | ||||||
| Hypersensitivity | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Infections and infestations | ||||||
| Abscess | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Bacteraemia | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Bacterial Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Beta Haemolytic Streptococcal Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Candidiasis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Catheter Related Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Catheter Site Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Clostridium Difficile Colitis | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Fungal Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Infected Skin Ulcer | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Lobar Pneumonia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Nasopharyngitis | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Oral Candidiasis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Osteomyelitis | 2/18 (11.1%) | 2 | 2/53 (3.8%) | 2 | 4/71 (5.6%) | 4 |
| Otitis Media | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Perianal Abscess | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Pneumonia | 0/18 (0%) | 0 | 3/53 (5.7%) | 3 | 3/71 (4.2%) | 3 |
| Sepsis | 2/18 (11.1%) | 2 | 5/53 (9.4%) | 5 | 7/71 (9.9%) | 7 |
| Skin Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Staphylococcal Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Upper Respiratory Tract Infection | 1/18 (5.6%) | 1 | 2/53 (3.8%) | 2 | 3/71 (4.2%) | 3 |
| Urinary Tract Infection | 4/18 (22.2%) | 4 | 9/53 (17%) | 9 | 13/71 (18.3%) | 13 |
| Urosepsis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Vaginal Infection | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Wound Infection | 0/18 (0%) | 0 | 3/53 (5.7%) | 3 | 3/71 (4.2%) | 3 |
| Wound Infection Staphylococcal | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Arteriovenous Fistula Site Complication | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Excoriation | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Joint Injury | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Overdose | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Post Procedural Haemorrhage | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Procedural Pain | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Thermal Burn | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Wound | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Wound Complication | 1/18 (5.6%) | 1 | 4/53 (7.5%) | 4 | 5/71 (7%) | 5 |
| Wound Secretion | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Investigations | ||||||
| Blood Albumin Decreased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Blood Cholesterol Decreased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Blood Potassium Decreased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Haematocrit Decreased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Haemoglobin Decreased | 1/18 (5.6%) | 1 | 1/53 (1.9%) | 1 | 2/71 (2.8%) | 2 |
| Heart Rate Increased | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Oxygen Saturation Abnormal | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Diabetes Mellitus | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Hyperkalaemia | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Hypokalaemia | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Nervous system disorders | ||||||
| Headache | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Muscle Spasticity | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Psychiatric disorders | ||||||
| Affective Disorder | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Anxiety | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Confusional State | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Depression | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Reproductive system and breast disorders | ||||||
| Epididymitis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Respiratory Failure | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Atelectasis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Hiccups | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Pharyngolaryngeal Pain | 1/18 (5.6%) | 1 | 3/53 (5.7%) | 3 | 4/71 (5.6%) | 4 |
| Pulmonary Embolism | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Respiratory Arrest | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Decubitus Ulcer | 1/18 (5.6%) | 1 | 1/53 (1.9%) | 1 | 2/71 (2.8%) | 2 |
| Ecchymosis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Erythema | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Pruritus | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Rash | 0/18 (0%) | 0 | 2/53 (3.8%) | 2 | 2/71 (2.8%) | 2 |
| Skin Burning Sensation | 1/18 (5.6%) | 1 | 0/53 (0%) | 0 | 1/71 (1.4%) | 1 |
| Skin Maceration | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Skin Necrosis | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Skin Ulcer | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Surgical and medical procedures | ||||||
| Tooth Extraction | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
| Vascular disorders | ||||||
| Hypotension | 0/18 (0%) | 0 | 1/53 (1.9%) | 1 | 1/71 (1.4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
RegeneRx (RGN) agreements may vary with individual PIs, but will not prohibit any PI from publishing. RGN supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | Nabila Turjman, PhD, Executive Director, Regulatory Affairs |
|---|---|
| Organization | RegeneRx Biopharmaceuticals, Inc. |
| Phone | 301-280-1992 ext 108 |
| nturjman@regenerx.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00382174
Other Study ID Numbers:
- SSPU
First Posted:
Sep 28, 2006
Last Update Posted:
Feb 1, 2010
Last Verified:
Jan 1, 2010